The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.
The US Food & Drug Administration (FDA) published an overview about HCT/P inspections in the last five fiscal years.
The European Medicines Agency (EMA), the European Commission and experts from the Member States issued a new Guide for Healthcare Professionals on Biosimilars.
The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.
The US Food & Drug Administration (FDA) plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide.
The FDA issued a Warning Letter objecting to inadequate microbiological testing and product contamination with Burkholderia Cepacia and other microorganisms and following adverse events. Find out more abou the FDA Warning Letter.
The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.
The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".