Berita Terbaru             -  INFORMASI AWAL UNTUK TENAGA PROFESIONAL KESEHATAN TERKAIT KEAMANAN PRODUK YANG MENGANDUNG BAHAN AKTIF RANITIDIN            -  INFORMASI AWAL UNTUK TENAGA PROFESIONAL KESEHATAN TERKAIT KEAMANAN PRODUK YANG MENGANDUNG BAHAN AKTIF RANITIDIN            -  Tecentriq (Atezolizumab) and New Important Identified Risk of Immune-Related Myositis            -  Actemra® (Tocilizumab) and Risk of Hepatotoxicity            -  Buletin Berita MESO Volume 37, No 1 Edisi Juni 2019

News

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)

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Agency for Food and Drug Administration continues to strive to make improvements and strengthening of pharmacovigilance systems in Indonesia, among others, with the development of drug side effect reporting system (ESO) electronically. ESO reporting system that has been running is paper based reporting system by using the yellow form (yellow form) by peer health workers and also CIOMS form by the pharmaceutical industry marketing authorization holder. Development of reporting ESO electronically is intended to expand outreach and access by health workers and the pharmaceutical industry in reporting ESO as an individual case safety report (ICSR) with timeline reporting more precise, so the National Agency of Drug and Food can immediately detect and identify if ESO there are serious problems (risk identification). In addition, it is expected with the development of this system, of course, good ESO reporting by peer health workers and the pharmaceutical industry marketing authorization holders can be further increased. In addition, all reports are received electronically ESO will be entered into the database meso, where POM can develop better data management as well. It is very important for POM to be able to do the analysis of the safety profile of the drug circulating in Indonesia, so that the POM can initiate the establishment of appropriate regulatory follow-up proactively with the profile data based on security aspects of the drug in a population of Indonesia itself. At this time, electronic reporting systems ESO is currently in internal testing phase by the POM as an administrator, so ready and mature during the soft launching implemented. The support of all parties in the form of criticism and suggestions is our motivation for POM to try to develop this system. (Saa)

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