- The Head of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") recently issued Decree No. 65 of 2022 on the List of Certain Generic Medications Required to Undergo Mandatory Bioequivalence Testing ("Decree 65/2022").
- The list includes 200 generic medications containing active ingredients that are now required undergo mandatory bioequivalence testing. These 200 generic medications have been divided into the following categories: 1) Respiratory (e.g. Salbutamol); 2) Diabetes (e.g. DPP-4 inhibitors); 3) Non-steroid anti-inflammatory (e.g. Piroxicam); 4) Immunosuppressant (e.g. Circlosporin); 5) Anti-thrombotic (e.g. Apixaban); 6) Cardiovascular (e.g. Antiaritmia); 7) Hormonal (e.g. systemic hormonal contraception); 8) Urinary (e.g. erectile disfunction medication); 9) Systemic anti-infection (e.g. Azithromycin); 10) Osteoporosis (i.e. all Bifosfonat derivatives); 11) Neurocentral system (e.g. antiepileptic medication); 12) Rheumatic and gout (e.g. Colchicine); 13) Anemia (e.g. Deferiprone); 14) Antineoplastic and immunomodulating agents (e.g. Imatinib); 15) Neuromuscular disorders (i.e. Tizanidine); 16) Other therapies (i.e. Ivermectin). The full list of generic medication can be accessed under the Appendix to Decree 65/2022.
- Decree 65/2022 states that any of the above-listed generic medications which are still undergoing the registration process, being newly registered and/or being reregistered and that are required to undergo bioequivalence testing may first undergo comparative dissolution testing if the parties concerned affirm their commitment to completing bioequivalence testing for the relevant products within two years of this Decree coming into force.
- Decree 65/2022 has been in force since 2 June 2022.
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