Recently EMA published a summary of its benefit-risk assessment efforts for centralised procedure products.

By end of April 2010 FDA issued the draft guidance entitled  "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" concerning devices.

This FDA Guidance for Industry aims to clarify key issues concerning Q8, Q9 and Q10.

Recently EMA published the "Concept paper on the Need to Develop an Appendix to the Guideline on Bioequivalence Regarding the Presentation of Biopharmaceutical and Bioanalytical Data in Application Dossiers".

The 7th Edition of the European Pharmacopeia will be released by the EDQM this year. There will be changes concerning the electronic version.

EMA offers an online training manual concerning  the topic  "Review of European Medicines Agency documents addressed to the general public by patients and consumers".

EMAs Committee for Medicinal Products for Human Use (CHMP) published a draft guideline concering the "Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections".

The European Commission published the draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" of the EU GMP Guide for a second public consultation.