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.
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.
During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.
In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.
The International Council for Harmonisation (ICH) recently published its proposed E9 Addendum to define the appropriate estimand for a clinical trial. Read more about the draft E9(R1) Addendum: Statistical Principles for Clinical Trials.
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.
The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.
There is a new commitment between EC, EMA and FDA allowing to share full inspection reports between agencies.
With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more about Tests for Subvisible Particles.