GMP News

The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. In addition, many countries outside Europe are preparing serialization systems. Internationally speaking, Russia is already very far advanced. Read more about the new requirements for Track&Trace in Russia.

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

The European Commission (EC) published an updated Version 2 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, 47 Q&As on safety have been included.

"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.

Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.

The FDA publishes an Untitled Letter to a manufacturer of stem cell products that are used to treat various diseases and are not expected to meet regulatory requirements.

In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

Two weeks ago, we pointed out in our News entitled MRA Countdown: 10, 6, 4, 2 that the Mutual Recognition Agreement (MRA) with the USA was on track. The News concluded with the statement that Germany and Slovakia were missing. Meanwhile, things have changed!

Quite a few authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what Russian inspectors will expect.

The British Medicines and HealthCare Regulatory Agency (MHRA) recently published the 2018 metrics report for serious GCP breaches reported to the agency.

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.