BPOM's Regulation Requires Offshore Manufacturing Facilities to Comply With CPOB Fulfillment
Drugs and Food Supervisory Agency (Badan Pengawas Obat dan Makanan or "BPOM") evaluates pharmaceutical manufacturing companies that apply for marketing authorizations for imported drugs ("Applicant") to ensure their compliance with the standards set out under the prevailing good manufacturing practice guidelines for drugs (Cara Pembuatan Obat Yang Baik or "CPOB").
CPOB guidelines are generally regulated under BPOM Regulation No. 34 of 2018 dated 7 December 2018 on Good Manufacturing Practice Guideline for Drugs ("BPOM Regulation 34"). BPOM issued BPOM Regulation No. 7 of 2019 dated 24 April 2019 on the Evaluation of the Fulfillment of CPOB Requirements on Manufacturing Facilities for Imported Drugs ("BPOM Regulation 7").
Content and Implications
BPOM Regulation 34 contains CPOB requirements that must be met by Applicants, while BPOM Regulation 7 focuses more on the requirements that are applicable to (and must be met by) the offshore Manufacturing Facility. Typically, 'Manufacturing Facilities' are owned by foreign pharmaceutical manufacturers (read: principals) that manufacture drugs outside of Indonesia and supply them into Indonesia through their appointed marketing authorization holder (i.e., Applicant) ("Principal Manufacturer").
- Under BPOM Regulation 7, 'Manufacturing Facilities' are defined as facilities used in a series of activities to produce imported drugs, including: (i) production and (ii) quality control; starting from the procurement of basic materials and pack aging materials, processing, pack aging until the product is ready for distribution as finished drugs.
- In general, all pharmaceutical manufacturing companies must comply with CPOB standards set out under BPOM Regulation 34 and obtain a CPOB certificate as proof of their compliance. In drugs registration (i.e., to obtain mark eting authorization), BPOM would want to ensure that the Manufacturing Facility (and the manufacturer) of the registered drug has met with the CPOB standards - or at least has met with the relevant good manufacturing practice ("GMP") standards applicable in the offshore country where the Manufacturing Facility is located (for imported drugs).