Asian Markets are becoming increasingly important for manufacturers in Europe and the U.S. The knowledge about the regulations in Asia is a key information for global engaged companies.

The European Commission (EC) started a public consultation on the technical aspects of the revision of the Directive on InVitro Diagnostic (IVD) Medical Devices (98/79/EC).

The FDA recently announced that they will focus on the issues of 21 CFR 11 (Part 11) by conducting a series of inspections. They aim to evaluate industry’s compliance and understanding of Part 11. Stress will be layed on the enforcement discretion described in the August 2003 "Part 11, Electronic Records; Electronic Signatures — Scope and Application" guidance.

Meet us at the 2010 PDA/ FDA Joint Regulatory Conference which will take place September 13-15 in Washington D.C. This year's conference theme is "The new Paradigm: Quality and Compliance in Merging and Emerging Cultures".

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) published four newly released Guidelines that were signed in Tallinn, Estonia, June 5-10, 2010. The Documents are now available on the ICH website.

Revised part II of EU GMP Guideline "Basic Requirements for Active Substances used as Starting Materials" will come into operation by July 31, 2010.

The European Commission has published the revised annexes 6 and 13 of the EU GMP Guideline some months ago. They come into operation on  July 31, 2010.

New GMP information about ICH meeting in Tallinn describes recent developments for the pharmaceutical industry.