GMP News - Regulatory Affairs

12.09.17

QbD: New EMA Guideline on Manufacture of the finished Dosage Form

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.

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12.09.17

Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.

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30.08.17

Brexit: the British comment

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.

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09.08.17

EMA updates Guidance for Post-Authorization Activities

The EMA announced on July 14, 2017, that it has revised three post-authorization activity guidance documents, including type II variations, post-authorization safety studies and changes related to quality aspects. Read more EMA´s updated post-authorizaiton guidelines.

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10.05.17

EMA-FDA QbD Pilot Program Report

In April 2017 the European Medicines Agency (EMA) published the final report of its joint pilot programme with the United States (US) Food and Drug Administration (FDA) for the parallel assessment of sections of applications relevant to quality by design (QbD). Read more about the final Report from the EMA-FDA QbD pilot program.

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23.11.16

Generics: FDA´s New Guidance on Prior Approval Supplements

Generics: The US Food and Drug Administration (FDA) recently published a new Guidance regarding Prior Approval Supplements (PAS). Read more about FDA´s Guidance for Industry "ANDA Submissions - Prior Approval Supplements Under GDUFA".

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05.10.16

GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

FDA's new Guidance requesting generic drug manufacturers who want to export to the USA to self-identify has recently been published in a finalised form. Read more here about what types of generic drug manufacturers are affected and which company data are required by the FDA.

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20.09.16

FDA´s New Regulations for Drug Manufacturers

The US Food and Drug Administration (FDA) finalized its revised regulations governing drug establishment registration and drug listing. Read more about the requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

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20.09.16

GVP Update

With this news we inform you about recent developments concerning EudraLex Volume 9 - Guideline on good pharmacovigilance practices (GVP). Read more about the revisions of GVP Module VI and IX (including Addendum) and published finals of GVP Module VIII and P.II on biological medicinal products.

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17.08.16

Recommendations from Health Canada for the Implementation of ICH Q3D

Recently in a notice, Health Canada has given its opinion about the implementation of the ICH Q3D guideline. Read more about which information on elemental impurities in applications for new marketing authorisations of medicinal products and OTC products, or in variation applications the Canadian Agency requires.

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03.08.16

New WHO guidance on variations to multisource pharmaceutical products

The World Health Organizaton (WHO) recently published a new Annex 10 on handling of variations. Find out more about the new WHO general guidance on variations to multisource pharmaceutical products.

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16.06.16

FDA releases new internal policy on ICH Q8, Q9, Q10 Guidelines

On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.

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23.05.16

EMA publishes QPPV Update

The European Medicines Agency (EMA) published the first issue of  its new "QPPV Update". Find out what´s new in Pharmacovigilance.

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23.05.16

EMA publishes Reflection Paper on Off-Label Use for Comment

The Europeam Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance“ for comment (deadline July 29, 2016). Read more about EMA's reflection paper on Off-Label-Use.

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23.05.16

EMA post-authorisation procedural advice for users of the centralised procedure

The European Medicines Agency (EMA) recently published an updated Questions and Answers paper on post-authorisation procedural advice for users of the centralised procedure. 

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