Pharmaceutical inspectorates around the world are trying to address the divergences between Europe’s good manufacturing practice guideline on gene therapy and tissue-engineered products and the international GMP guideline for such products.
Concerns over the controversial EU guideline on good manufacturing practice requirements for advanced therapy medicinal products (ATMPs) have prompted the regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization to create a new working group to suggest possible solutions.
Regulators around the world are worried about divergences between the EU GMP ATMP guideline, which was finalized last year, and...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
