GMP News - Regulatory Affairs

17.10.17

Similarity by Design: EMA Reflection Paper on statistical Methodology for comparative Assessment of QAs

The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

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20.09.17

FDA aligns Inspection and Regulatory Affairs Systems

The US Food & Drug Administration (FDA) plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide.

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14.09.17

EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions

The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".

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14.09.17

EMA updates Website on Mutual Recognition Agreements

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

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13.09.17

API starting materials - New Q&A document for ICH Q11

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.

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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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