This quarter marks the breakthrough of data-integrity as a new important element of GMP-systems worldwide. While the MHRA already issued its Guidance for Industry in March 2015, in April 2016 the FDA issued a similar guideline. So we will have to prepare ourselves for this theme to arrive on the table during GMP-audits. For that purpose we will have to perform internal data-integrity audits with our clients as of now. The first of such internal audits is planned in July 2016. If you are interested in this item contact Susil Chotoe at our office.
Data is also what marketing authorization applications are about and in June 2016 we managed to finalize two Decentralized Procedures which we executed on behalf of a generic company. One of these was rather uncomplicated but for the other one we had to attend an EMA-meeting in London to discuss serious issues about the synthesis-data of the active ingredient. However, the evaluators of the reference member state (The Netherlands) took a constructive and sympathetic position, thanks to which we were able to come to a positive conclusion at Day 210.
Talking about data and the EMA, it is now rumoured that doubts emerge in the EMA offices in London what to do with the massive amount of pharmacovigilance data they are currently receiving from drug companies regarding the numerous medicinal products circulating within the European pharmaceutical market. Does it really deliver “value for money” asking these pharmaceutical companies to put so much money and effort in collecting these data? Not to mention the numerous inspectors in the various member states performing vigilance audits within such companies as they did within our premises last week. Only time will tell if this “big data project” will deliver or fail, but regardless the outcome we will have learned quite a lot from it. If it were only to prevent the medical devices industry from entering the same dead end street in case it indeed appears a “big deal”.