The first Indonesia-Japan symposium On: Ensuring Quality, Safety, Efficacy Through Integrity Supply Chain, which co-hosted by National Agency of Drug and Food Control/ Badan Pengawas obat dan Makanan Indonesia (NADFC/BPOM), Gabungan Perusahaan Besar farmasi Indonesia (GPFI), Pharmaceutical And Medical Devices Agency (PMDA), and also Japan Pharmaceutical Manufacturers Association (JPMA), was held on February 13th -14th 2013 at Red Top Hotel, Jakarta.
In the symposium, representatives from regulatory agencies, pharmaceutical industries and distributors from both Indonesia and Japan gave presentation on update of pharmaceutical situations, Pharmacovigilance, and Good Distribution Practice (GDP) of each country.
Pharmacovigilance Implementation in Indonesia
Pharmacovigilance (PV), which is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, is being implemented in Indonesia step by step. In the opening ceremony of the symposium, Johannes Setijono, Apt., said that, “If we perceive that the implementation could not be instantly realized, now it is time for us to learn from Japan’s long history of pharmacovigilance to enrich insight and wisdom in the implementation of pharmacovigilance that is suit conditions in the pharmaceutical industry and distribution in Indonesia”.
At the event, Head of National Agency of Drug and Food Control (NADFC/BPOM), Lucky S. Slamet, M.Sc., inform several strategies to strengthen drug control regulatory system in the framework of pharmacovigilance implementation in Indonesia. Some of the strategies are, increase post-market control of drug product, consolidation of regulation and standard in drug control, and also increasing competency and professionalism of the staffs in the field of distribution control. NADFC has also enacted regulation No HK.03.1.23.12.11.10690 about Pharmacovigilance Implementation for Pharmaceutical Industry to strengthen the structure of pharmacovigilance system in Indonesia.
Good Distributin Practice (GDP) Implementation In Indonesia
The implementation of pharmacovigilance closely related to the manner of good distribution practice, as by the implementation of GDP, the quality of the drug can be maintained until into the hands of the customers, and ensure the traceability if there is any adverse drug reaction.
NADFC also conduct distributor mapping to ensure that the drug distributor run their activities based on GDP, and certification for distributors who implement GDP/CDOB consistently. In the past two years (2010-2012) NADFC has already mapped 918 from 2500 drug distributors in Indonesia.
PT. Anugrah Argon Medica (AAM), as the largest pharmaceutical distributor in Indonesia, which consist of 40 branches in all over Indonesia, 24 of them have been certified GDP/CDOB and the rest are still in certification process and will be done in June 2013 approximately. This shows AAM’s commitment in maintaining the quality and safety of pharmaceutical products along the distribution supply chain.
Also participate as the speaker, Erwin Tenggono, AAM’s advisor, gave speech entitled GDP Implementation: Business and Ethics. Erwin said that many advantages can be gained if a company implement GDP as the standard for continuous improvement, and for pharmaceutical business, GDP is a belief, system, and tools. GDP can be a part of competitive advantages, if it is implemented as a part of business strategy.
Hiroshi Ichijo, Chairperson of The Pharmaceutical Regulation Committee the Federation of Japan Pharmaceutical Wholesalers Association, delivered speech about Japan Good Supply Practice (JGSP) as a requirement that pharmaceutical wholesalers need to comply with in distribution and quality control, and it is established under the fundamental philosophy to put quality maintenance in distribution above commercialism, which pharmaceutical wholesalers easily autocratic.
Comentarios