ETHREL ETHEPHON GROWTH REGULATOR

Main information

  • Trade name:
  • ETHREL ETHEPHON GROWTH REGULATOR
  • Class:
  • AgChem
  • Medicine domain:
  • Plants
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ETHREL ETHEPHON GROWTH REGULATOR
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • APPLE | APPLE - LEGANA | APPLE - STARK CRIMSON | CHERRY | CHERRY - FLORENCE | CHERRY - NAPOLEON | CHERRY - RON'S SEEDLING | CHER
  • Therapeutic area:
  • GROWTH REGULATOR
  • Therapeutic indications:
  • ACCELERATE RIPENING | ADVANCE OR DELAY MATURITY (INC. RIND) | ADVANCE/CONCENTRATE FRUIT MATURITY | EVEN OUT PRODUCTION CYCLE | FRUIT THINNING | INCREASE FRUIT MATURITY OR COLOUR | INCREASE FRUIT SIZE OR HASTEN MATURITY | INCREASE FRUIT YIELD | INITIATING FLOWERING | PROMOTE DESIRABLE HARVEST EFFECTS | PROMOTE FRUIT SKIN OR FLESH COLOUR | REDUCE SIZE OF HEAVY CROP | REDUCE VEGETATIVE GROWTH | CONTROL EXCESS VINE GROWTH | CONTROL EXCESS.VEG.GROWTH | DELAY AGEING | DELAY HARVEST | DELAY MATURITY | FRUIT THINNING | INCREASED RED COLOUR | INCREASING FRUIT YIELD | PROMOTES FLOWERING | REDUCE FIRE HAZARD/ WEED GROWT

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Archived
  • Authorization number:
  • 33338
  • Last update:
  • 09-08-2016

23-1-2019

Peer review of the pesticide risk assessment of the active substance Verticillium albo‐atrum strain WCS850

Peer review of the pesticide risk assessment of the active substance Verticillium albo‐atrum strain WCS850

Published on: Wed, 16 Jan 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co‐rapporteur Member State the Netherlands for the pesticide active substance Verticillium albo‐atrum strain WCS850 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representa...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Peer review of the pesticide risk assessment of the active substance fenamiphos

Peer review of the pesticide risk assessment of the active substance fenamiphos

Published on: Mon, 21 Jan 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Cyprus for the pesticide active substance fenamiphos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fenamiphos as a nematic...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Pest categorisation of Phyllosticta solitaria

Pest categorisation of Phyllosticta solitaria

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Pest categorisation of Grapholita prunivora

Pest categorisation of Grapholita prunivora

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Published on: Thu, 13 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions w...

Europe - EFSA - European Food Safety Authority Publications

3-12-2018


Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Europe - EMA - European Medicines Agency

29-11-2018


Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Europe - EMA - European Medicines Agency

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Published on: Mon, 26 Nov 2018 In the framework of the project ‘Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2’ a compendium of representative processing techniques was prepared as a result of Objective 1. In Objective 2 the food / feed items and processes as described in the compendium of Objective 1 were coded using the FoodEx2 coding system. The coding covers the raw agricultural commodities and the food / feed item...

Europe - EFSA - European Food Safety Authority Publications

23-11-2018

Canadian Tire recalls Mastercraft 5 Gallon Air Compressor

Canadian Tire recalls Mastercraft 5 Gallon Air Compressor

Regulator knob may break off under pressure and may lead to a component failure and cause injury to consumers.

Health Canada

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-1-2019


Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

We seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Europe - EMA - European Medicines Agency

19-12-2018

Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018

Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018

The TGA has published its Self-Assessment Report for 2017-18

Therapeutic Goods Administration - Australia

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

2-12-2018

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt

FDA - U.S. Food and Drug Administration

1-12-2018

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation.  https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

. @US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre  pic.twitter.com/XiTbPfEkcj

FDA - U.S. Food and Drug Administration

30-11-2018

Consultation: Regulatory options for appropriate access and safety controls for alkyl nitrites

Consultation: Regulatory options for appropriate access and safety controls for alkyl nitrites

Discussion paper outlining different approaches to access and safety controls for alkyl nitrites

Therapeutic Goods Administration - Australia

28-11-2018

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

Clarification of ISO 13485 certificates for IVD medical devices

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

27-9-2018

Read about how the FDA is seeking more resources in FY2019 to help  advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while  protecting patients. Click here:  https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency