The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.
The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").
The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.
In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?
Switzerland has begun to enter information on GMP inspections into the EMA database.
In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.
In a letter, the EU Commission explains possible exemptions for future batch testing in the UK.
After the legal situation for medical cannabis in Germany has already changed in 2017, the World Health Organization (WHO) has now proposed a global re-classification of the addictive potential of cannabis.
FDA inspectors usually expect a minimum level of GMP understanding for identity and assay determinations of starting materials and finished products. Read here which basic GMP deficiencies in the quality control laboratory have led to a Warning Letter regarding incoming goods controls and testing of finished products.