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?
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?
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.
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.
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.
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.
The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.
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?
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.
The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.
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.
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.
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.
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?
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.