Accelerated Drug Approval in Indonesia
The Indonesian government is accelerating the registration of companies and pharmaceutical products to help in fighting COVID-19.
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To aid in combating COVID-19, Indonesia’s National Agency for Drug and Food (BPOM) is accelerating the registration of drugs and biological products. The agency is simplifying registration requirements and prioritizing the assessment of drugs used in COVID-19 handling as stated in a press release.
Only pharmaceutical companies in Indonesia can register drugs and biological products. Local pharmaceutical companies may import drugs if they have written approval from the overseas company producing the product.
The Investment Coordinating Board (BKPM) issued a decree on April 1, 2020 to grant ease of licensing for businesses related to the handling of COVID-19. The decree will remain in effect until the end of COVID-19 emergency response status as declared by the National Disaster Management Agency.
Per the decree, the BKMP is providing ease of licensing by reducing requirements and accelerating the business licensing process.
This is a very good time to open a pharmaceutical company in Indonesia. In fact, the BKPM reports that there has been a significant increase in the number of licenses issued to businesses in the health sector.
Emerhub can assist in registering your pharmaceutical company in Indonesia. Get in touch with us using the form below or by emailing [email protected].
Acceleration of registration applies to some drugs used in the management of COVID-19 under the following categories:
Special Pre-registration of Drugs and Biological Products
Pre-registration of new drugs, biological products, first generic drugs, generic drugs that require bioequivalence testing, and imported drugs under current conditions takes 6 hours instead of 40 working days.
Special Registration of New Medicines and Biological Products
BPOM is allowing quicker licensing for drugs with new active substances or the addition of indications. Registration of qualified drugs is 20 working days.
Additionally, clinical and non-clinical data submitted does not need to be in full accordance with the regular provisions for drugs. It just needs to be enough to provide information on the use of the drugs during a pandemic outbreak in Indonesia or other countries.
Evaluation of these drugs considers relevant benefits and risks. Should the benefits outweigh the risks, the BPOM may grant conditional approval. Provisions of conditional approval are the following:
- Usage. Restricted use for designated hospitals to facilitate monitoring the efficacy and safety of the drugs.
- Confirmation. The drugs are subject to post-approval clinical studies in Indonesia using data on the use of the drug after approval.
- Reevaluate. BPOM may review or reevaluate aspects of efficacy and safety of the drug.
Special Registration of New Generic Drugs
BPOM is also prioritizing registration and evaluation of new generics drugs. BPOM will also allow for some exemptions in terms of testing and risk analysis. From the usual 150 working days, this process will only take a maximum of 5 working days for qualified drugs.
BPOM may grant conditional approval for these items. Provisions of conditional approval include:
- Confirmation. Conduct a full bioequivalence test in Indonesia after approval, if required.
- Reevaluation. BPOM has the right to review and/or reevaluate aspects of efficacy, safety, and quality of the drug if new evidence is found relating to those.
The Indonesian government issued a special access scheme (SAS) for drugs, medical devices, and raw materials used in developing drug products needed in handling the virus. Documents required for applying for SAS include:
- Application for recommendations and details of items
- Packing list
- Airway bill
- Certificate of analysis
The BPOM made guidelines for COVID-19 drugs and donations that are coming into Indonesia through special channels to prevent and control the spread of COVID-19.
The examination of these imports includes these steps:
- Coordinating with the relevant stakeholders.
- Checking the import documentation to see if the items match the description and quantity stated.
- Evaluating the physical condition and information of the drugs including the name, content, dosage/strength, and expiration date.
- Evaluation of the drugs through physical testing
- Distributing drugs to appointed health care facilities, monitored by the relevant authorities
Emerhub’s team of experts are ready to help you in getting approval for drugs and other pharmaceutical items in Indonesia. Contact us using the form below or by emailing [email protected]. Let us help you import essential items to Indonesia.
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