GMP News - Regulatory Affairs

21.06.22

What is a Complex Clinical Trial?

In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?

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21.06.22

Clinical Trials Regulation - Version 6.1 of the Q&As

The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?

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08.06.22

USP intends to revise the Chapters on Microbiological Control of Non-sterile Medicinal Products

In PF46(2), the United States Pharmacopoeia has published a Stimuli article addressing the planned revision of chapters relevant to microbiological control of non-sterile products.

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25.05.22

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

The EMA published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided.

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18.05.22

Data Protection of Information Uploaded in the CTIS

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

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18.05.22

Clinical Trials - ICH E11A on Pediatric Extrapolation

The ICH E11A draft reached Step 2 of the ICH process. The guideline describes the extrapolation framework consisting of the pediatric extrapolation concept and the pediatric extrapolation plan.

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18.05.22

List of Documents Needed during GCP Inspections

The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.

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11.05.22

Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?

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11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

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10.05.22

What is a Pregnancy Prevention Programme?

The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.

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05.05.22

Update of the EMA Q&As on parallel Distribution of Medicinal Products

The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.

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05.05.22

EDQM updates List of available Reference Standards

Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.

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05.05.22

FDA publishes updated PQ/CMC Document for Comments

In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange document" for comments.

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04.05.22

EMA´s Cannabis Glossary

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?

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27.04.22

Requirements for Styrene Block Copolymers

Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.

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