In our News dated 25 September 2017, we announced the finalisation of an FDA guideline for the qualification of development tools for medical devices. Since this topic is very important for the FDA, a website has been dedicated to it. It is available on the Internet.
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.
New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.
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 numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
The new CTR becomes applicable six months after the notice of the full functionality of the CTIS. The EMA informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit.
The GMP regulations contain many indefinite legal terms. Procedures and processes should be appropriate, regularly repeated, or sufficient. Now, the question is how to concretise appropriate, regularly repeat and sufficient?
With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.
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.
Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.
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!