Լաքսալակ

main_info

  • trade_name:
  • Լաքսալակ
  • dosage:
  • 670մգ/մլ100մլ ապակե շշիկ և չափիչ բաժակ, 200մլ պլաստիկե շշիկ և չափիչ բաժա
  • pharmaceutical_form:
  • լուծույթ ներքին ընդունման
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Լաքսալակ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

12-4-2019

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

Published on: Thu, 11 Apr 2019 The European Union (EU) pesticides Regulation established that in vitro comparative metabolism studies shall be performed. At present an Organisation for Economic Co‐operation and Development (OECD) test guideline for this kind of studies is not available. The European Food Safety Authority (EFSA) Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment discussed the use of these studies to identify human metabolites and to support the as...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-4-2019

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA - U.S. Food and Drug Administration

2-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

FDA - U.S. Food and Drug Administration

29-3-2019

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Published on: Thu, 28 Mar 2019 This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain o...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted

Published on: Thu, 28 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co‐rapporteur Member State the Czech Republic for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

FDA announced several new actions as part of our commitment to ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health.

FDA - U.S. Food and Drug Administration

15-3-2019

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

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

Published on: Thu, 14 Mar 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 the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid 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 thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including Africa.

Danish Medicines Agency

11-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance

FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply.

FDA - U.S. Food and Drug Administration

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.

FDA - U.S. Food and Drug Administration

21-2-2019

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States

FDA - U.S. Food and Drug Administration

21-2-2019


Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Europe - EMA - European Medicines Agency

8-2-2019

Bee protection: ANSES makes recommendations to strengthen the regulatory framework

Bee protection: ANSES makes recommendations to strengthen the regulatory framework

As part of the Government's action plan on plant protection products and reduced dependence on pesticides in agriculture, ANSES is today publishing the results of its expert appraisal and its recommendations to strengthen the regulatory framework for the protection of bees and other pollinating insects. The aim of these recommendations is to further reduce bee exposure to plant protection products.

France - Agence Nationale du Médicament Vétérinaire

1-2-2019

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

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

Published on: Thu, 31 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 imidacloprid. To assess the occurrence of imidacloprid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import to...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

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

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

Published on: Thu, 31 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 hexythiazox. To assess the occurrence of hexythiazox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Commission as well a...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

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

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

Published on: Wed, 23 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 spiromesifen. To assess the occurrence of spiromesifen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission, as well as the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

11-4-2019


The role of regulators in establishing added benefit of novel therapies

The role of regulators in establishing added benefit of novel therapies

The role of regulators in establishing added benefit of novel therapies

Europe - EMA - European Medicines Agency

8-4-2019

TGA presentation: How the TGA regulates software, 7 March 2019

TGA presentation: How the TGA regulates software, 7 March 2019

This webinar discusses how the current regulatory scheme applies to software.

Therapeutic Goods Administration - Australia

4-4-2019

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert:  https

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert: https

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert: https://go.usa.gov/xmcFa .

FDA - U.S. Food and Drug Administration

4-4-2019

Dr. Gottlieb has been a strong partner in innovating the FDA’s proposed regulatory approach to #DigitalHealth and was proactive in reimagining medical device oversight.

Dr. Gottlieb has been a strong partner in innovating the FDA’s proposed regulatory approach to #DigitalHealth and was proactive in reimagining medical device oversight.

Dr. Gottlieb has been a strong partner in innovating the FDA’s proposed regulatory approach to #DigitalHealth and was proactive in reimagining medical device oversight.

FDA - U.S. Food and Drug Administration

3-4-2019

An Action Plan for Medical Devices

An Action Plan for Medical Devices

The Action Plan will further improve Australia’s medical device regulatory system and place patient safety first

Therapeutic Goods Administration - Australia

3-4-2019

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Active substance: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2019)2666 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002333

Europe -DG Health and Food Safety

29-3-2019

Submission of an updated RMP

Submission of an updated RMP

Use this form when submitting an updated RMP after regulatory approval

Therapeutic Goods Administration - Australia

28-3-2019

Federal Register Notice: On March 27th the @US_FDA issued a Proposed Rule – Mammography Quality Standards Act; Regulatory Amendments. Read more about the rule and submit either electronic or written comments on the proposed rule by June 26, 2019:  https:/

Federal Register Notice: On March 27th the @US_FDA issued a Proposed Rule – Mammography Quality Standards Act; Regulatory Amendments. Read more about the rule and submit either electronic or written comments on the proposed rule by June 26, 2019: https:/

Federal Register Notice: On March 27th the @US_FDA issued a Proposed Rule – Mammography Quality Standards Act; Regulatory Amendments. Read more about the rule and submit either electronic or written comments on the proposed rule by June 26, 2019: https://go.usa.gov/xESWX 

FDA - U.S. Food and Drug Administration

28-3-2019

EU/3/13/1217 (SFL Regulatory Services GmbH)

EU/3/13/1217 (SFL Regulatory Services GmbH)

EU/3/13/1217 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2428 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004699

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1216 (SFL Regulatory Services GmbH)

EU/3/13/1216 (SFL Regulatory Services GmbH)

EU/3/13/1216 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2427 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004691

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1215 (SFL Regulatory Services GmbH)

EU/3/13/1215 (SFL Regulatory Services GmbH)

EU/3/13/1215 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2426 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004666

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1214 (SFL Regulatory Services GmbH)

EU/3/13/1214 (SFL Regulatory Services GmbH)

EU/3/13/1214 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2425 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004351

Europe -DG Health and Food Safety

20-3-2019

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices

Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices

Therapeutic Goods Administration - Australia

15-3-2019

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.  https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. https://go.usa.gov/xE6Ws 

FDA - U.S. Food and Drug Administration

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Active substance: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d]pyrimidin-4-one) - Transfer of orphan designation - Commission Decision (2019)1942 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004496

Europe -DG Health and Food Safety

7-3-2019

Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites

Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites

Communique summarising outcomes of the alkyl nitrites public meetings in Sydney and Melbourne

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

6-3-2019

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

Consultation: Proposed changes to the classification of active implantable medical devices and their accessories

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

1-3-2019


Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1750 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004372

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1749 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004369

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1748 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004343

Europe -DG Health and Food Safety

14-2-2019

EU/3/11/914 (Quality Regulatory Clinical Ireland Limited)

EU/3/11/914 (Quality Regulatory Clinical Ireland Limited)

EU/3/11/914 (Active substance: Smilagenin) - Transfer of orphan designation - Commission Decision (2019)1374 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003741

Europe -DG Health and Food Safety

12-2-2019

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

The TGA is seeking feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

11-2-2019

Consultation: Proposed reclassification of spinal implantable medical devices

Consultation: Proposed reclassification of spinal implantable medical devices

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

6-2-2019

Zycortal (Dechra Regulatory B.V.)

Zycortal (Dechra Regulatory B.V.)

Zycortal (Active substance: desoxycortone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)914 of Wed, 06 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3782/T/02

Europe -DG Health and Food Safety

31-1-2019

Regulatory options for appropriate access and safety controls for alkyl nitrites - Public meeting questions and answers

Regulatory options for appropriate access and safety controls for alkyl nitrites - Public meeting questions and answers

Alkyl nitrites public meeting questions and answers are now available

Therapeutic Goods Administration - Australia

25-1-2019

Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites

Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites

The TGA would like to thank respondents who provided submissions in response to the November 2018 public consultation paper

Therapeutic Goods Administration - Australia

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