More recently, precisely in December 2010, has issued regulations related to setting the role of the pharmaceutical industry as the holder of the marketing authorization in the activities of pharmacovigilance in Indonesia, namely the Minister of Health Regulation No. 1799 / Menkes / Per / XII / 2010 on the Pharmaceutical Industry , In Article 9 of Permenkes in mentioning that the Pharmaceutical Industry must conduct farmakovigilans.
This is an effort that has been made of POM to elevate the role of the pharmaceutical industry as a marketing authorization holder, as a form of responsibility to ensure that the circulation of the drug that is meet the requirements of safety, efficacy and quality. POM efforts in this regard, starting from socialization pharmacoviglance first to the pharmaceutical industry in late 2007 (which is the initial stage of the process steps or pre-regulation). Followed pharmacovigilance workshop to the pharmaceutical industry in the following years, 2008 and 2009. In 2010, POM file a chapter on pharmacovigilance as part of a revision of the previous Permenkes governing the pharmaceutical industry. This is a significant regulatory developments and become a very strong legal base for pharmacovigilance activities in Indonesia.
Actually, the provisions on the responsibility of the pharmaceutical industry in pharmacovigilance or escort outstanding aspects of drug safety, has been emphasized also in the Minister of Health No. 1010 / Menkes / PER / XI / 2008 on Drug Registration.
Thus, regulatory support related to pharmacovigilance activities in Indonesia became strong enough. The next step is how implementation can be done either by POM as a drug regulatory authority and the pharmaceutical industry as well as targets for surveillance. In this case, POM has made the preparation of Draft Guidelines for Pharmaceutical Industry Pharmacoviglance, which can be used as a technical guide for the pharmaceutical industry to initiate the pharmacovigilance system in the organization. The draft guidelines also expected to be approved in the not too long, to support the new regulations that have been determined. (saa)