News

Safety Features - how is it progressing?

The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

More
Defect Catalog for Films and Foils

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.

More
New Zealand proposes new legislation for medical cannabis

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.

More
New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

More
GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

More
New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 

More
Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

More
Drug Shortages due to Brexit: EU gives Answers

The EMA has published a question-and-answer document on possible supply bottlenecks after Brexit.

More
Brexit: GDP Updates for Import Activities and Air Freight

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

More
Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

More
x
Search