In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).
In July, new topics were added to the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC".
On 14 April 2020, the Brazilian regulatory authority ANVISA published a new guideline for the validation of computerised systems which is to replace the guideline of the same name from 2010. Find out more about the main contents and further developments here.
In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described.
The topic data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 9: Must data flow diagrams be available?
The Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.
The European Pharmacopoeia (Ph. Eur.) has published the revised chapter 2.2.48 on Raman Spectroscopy for public consultation. All interested users are encouraged to review the draft and submit their comments from July to September 2020.
The World Health Organization (WHO) has published a draft proposal for revision in The International Pharmacopoeia. The document entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS will be posted on the WHO Medicines website. The deadline for comments is 31 August 2020.
Emer Cooke from Ireland will be the new director of the European Medicines Agency (EMA) in Amsterdam. This was announced by the EMA Management Board.
A FDA draft guideline entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers has now been finalized.