Recently, the revised Ph. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more about the revised monograph on the dosage form Tablets.
In the manufacturing and release of IMPs, not all requirements of Annex 16 can be transferred one to one. MHRA is now trying to clarify the most important questions.
The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Find out more about the revised Q&A document of the EU about safety features.
During an inspection, the french authorities found major deficiencies at the site of a Brazilian manufacturer of sterile medicinal products. Learn more details about the EMA's non-compliance report.
The European Institute for Pharma Logistics (EIPL) conducted a field study on drug deliveries by online pharmacies - with some alarmingly results. Find out more about the EIPL field study.
FDA's new automated system to assist in making import decisions for FDA-regulated products seems to shorten up processing time, according the agency. Learn more about the FDA Automated Commercial Environment/International Trade Data System.
Marketing Authorisation Holder (MAH) might require Pharmacovigilance Agreements with Wholesale Distributors according to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.
Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.
The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.