The CMDh, CMDv and EMA Q&A document "Q&A on Active Substance master file (ASMF)", last revised in March 2022, has been updated again and published on the HMA (Heads of Medicines Agencies) website in the CMDh section.
The FDA has signed a Mutual Recognition Agreement on GMP inspections with Switzerland. It applies to both human and veterinary medicinal products.
The European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated.
In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.
Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 2: What cloud models are there and where do they have applications in the GxP environment?
In the Pharmeuropa issue 35.1, a proposal for a revised chapter 2.9.3. Dissolution test for solid dosage forms was published. The deadline for submitting comments is 31 March 2023.
As already reported a few months ago, a revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. One of the changes is the sensitivity requirement. In this context, the EDQM has now published a press release, stating that this change might be technically challenging for a number of users. Therefore, there will be another revision.
The UK government consulted stakeholders on an important decision regarding batch testing and certification. The result is that it should remain as it is.
The agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.
In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. Following the previous update on how to manage clinical trials transitioned to the CTR, the EMA now clarifies the timelines for the transition period.