The topic of electronic records / electronic signatures is again on the FDA's current agenda. On 8 July 2010, the Agency announced that it would increasingly focus on the implementation of the 21 CFR Part 11 requirements during upcoming inspections. Read more here.
European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.
The European Commission has published on the EudraLex - Volume 4 webpage the new Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice. The new Annex is coming into force in July 2010. Read what's new.
To provide guidance to manufactueres of influenza vaccines on the quality issues associated with isolating candidate vaccine viruses in cell culture, the EMA lays down the quality recommendations for cells used to isolate candidate influenza vaccine viruses in a new draft guideline, which is open for consultation until September 2010. More information can be found here.
The FDA announces the draft of a guidance for medical device manufacturers aiming at including audit results according to ISO 13485 into a risk-based working programme by the FDA. One of the objectives is a reduction in FDA inspections. Read more here.
The European Commission has published a public consultation document: Draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ('CT-3'). Read more.
On 20 May 2010 the Danish Medicines Agency (DMA) published results of a survey to examine the extent to which manufactureres of medicinal products comply with their obligation to ensure that APIs used in the manufacture of medicinal products comply with the GMP regulations. A number of deficiencies have been identified which need to be remedied in the future. You will find more here.
The FDA proposed an updated regulation to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in clinical trial studies involving human or animal subjects. Read more.
The European Commission has decided to establish a European database for medical devices (Eudamed) in order to be able to access safety-relevant data more quickly. Furthermore, it will help to facilitate the registration procedure for IVDs. Read more here.
In May, FDA published the new Guidance for Industry "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products". More information can be found here.
The European Medicines Agency has published for public consultation a reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA. Read more.
USP is seeking submission of proposals to support the modernization of USP-NF small molecule and excipient monographs that utilize outdated technology (e.g., use of packed gas chromatography columns), have safety/environmental concerns (e.g., chlorinated solvents, etc) or are missing procedures for key aspects such as impurities. Click here to read more.