Regulation of drug registration and approval

Under government law the Badan Pengawas Obat dan Makanan (BPOM) or National Agency of Food and Drug Control (NAFDC) is responsible for the pre-market evaluation of safety and marketing of all medicines. Its functions also include regulation, standardization and Good Manufacturing Practice (GMP) certification of medical and food producers. Manufacturers can produce and market medicines only after clearance by NAFDC, following a registration process with strict criteria drawn from the Swedish regulatory model (DepKes, 2008b). Manufacturing can only start if firms hold a GMP certificate, which forms the initial requirement for drug registration. The GMP certificate specifies the dosage form of the product for manufacturing. Other data on efficacy, safety (with toxicology studies), manufacturing processes with specifications about brand name, packaging and so on are included in the documentation necessary for obtaining regulatory approval. For new products, such approval and fulfilment of all registration requirements should by rights take no more than one year. In practice, it takes approximately three years for new product approvals post first registration submission. After NAFDC registration approval, promotional and marketing material should comply with claims approved in the regulatory application (Badan Pom, 2002). Promotion material for both prescription and over- the-counter (OTC) products requires preliminary approval by NAFDC of all written material, and rough sketches of pictures or video material have to be submitted. This clearance also takes time, so applicants must have a good understanding of all rules and regulations to manage the launch of new products.

As a member of Association of Southeast Asian Nations (ASEAN), Indonesia is working with other members for the realization of regional free trade (ASEAN, 2009a), as a follow-up of formerly agreed activities (ASEAN, 2007). Recently, NAFDC and its respective partner food and drugs authorities from other ASEAN countries have conducted a number of meetings to discuss the format and content of the harmonized ASEAN Common Technical Dossiers (ACTD) for prescription (generics and patented products) as well as OTC drug applications. ACTD is actually a guideline for an agreed common format for the preparation of Common Technical Dossier applications to ASEAN regulatory authorities for the registration of pharmaceuticals for human use (ASEAN, 2009b). ACTDs require a complete record of all the active pharmaceutical products and their excipients (the inactive compounds used as carriers or media for active ingredient delivery) used in a particular drug, as well as details of labelling and quality and (non-)clinical data. NAFDC has implemented the ACTD format for drugs submitted since 2009, resulting in a decline of new drug approvals, for both drugs encompassing new chemical entities and generic drugs. NAFDC's 2008 application for membership of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is currently in the evaluation process. PIC/S are two international instruments that have been agreed among countries and pharmaceutical inspection authorities that provide active cooperation in the field of GMP.

The purpose of PIC/S is to take a lead in the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products (Pic/S, 2011). This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; by training competent authorities (in particular inspectors); through assessing (and reassessing) inspectorates; and by facilitating the cooperation and networking of competent authorities and international organizations (Pic/S, 2008). Indonesia was expected to become a full member of PIC/S in 2012, following in the footsteps of its neighbouring countries, Singapore (2000) and Malaysia (2002) (Pic/S, 2011). In becoming a PIC/S member, NAFDC is expected to step up its quality inspection of manufacturing facilities, leading to an overall improvement in the quality of medicines.

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