To enter the Indonesian pharmaceutical market, a drug should acquire marketing authorization granted by the Jaringan Dokumentasi Dan Informasi Hukum (Badan POM/BPOM), also known as the Indonesian Food and Drug Administration (FDA).
As stipulated in the country’s Criteria and Procedures for Drug Registration, obtaining marketing authorization necessitates successful registration with the Indonesian FDA. This article will outline the steps for registering a drug in Indonesia.
1. Applicant’s Qualification
For the registration of local drugs, applicants are generally required to have both a pharmaceutical industry license issued by the Ministry of Health and a valid Good Manufacturing Practice (GMP) certificate in accordance with the registered type and dosage form.
Regarding the registration of imported drugs, applicants must secure written approval from the pharmaceutical company abroad, unless the applicants are affiliates to the parent company. The foreign company should have a license in the pharmaceutical industry and possess both a valid GMP certificate and inspection report issued by the authority in the country of origin. The Indonesian FDA may conduct on-site inspections to verify GMP fulfillment.
2. Product Classification
In Indonesia, new drug, investigational new drug, generic drug, branded generic drug, first generic drug are common terms used in the categorization of registration.
Table 1: Common terms related to drug registration in Indonesia
Product | Definition |
New drug | A drug with a new chemical entity, new dosage form, new strength, or new combination having never been approved in Indonesia. |
Investigational new drug (IND) | A drug product or drug substance in the form of a new molecule or new formula, biological product/biotechnology being developed and manufactured by a research institution or pharmaceutical company in Indonesia and/or abroad for use in the nonclinical and/or clinical trial stages in Indonesia with the aim of obtaining a marketing authorization in Indonesia. |
Generic drug | A drug with the name according to International Nonproprietary Names (INN) modified and determined by the World Health Organization (WHO) or the name specified in Indonesia’s national health program. |
Branded generic drug | A drug with trade names containing active pharmaceutical ingredients (APIs) with the same composition, strength, dosage form, route of administration, indications, and posology with originator drugs that have been approved in Indonesia. |
First generic drug | The first generic drug registered in Indonesia with the same APIs as the originator drug approved in Indonesia |
3. Registration Category
According to Indonesia’s Criteria and Procedures for Drug Registration, which took effect in 2017 and was last amended in 2021, drug registration is classified into the following categories:
Table 2: Drug registration categories in Indonesia
Registration category | Description of category | |
New registration | Registration for drug that have not obtained a marketing authorization in Indonesia | Category 1: Registration of new drugs and biological products, including biosimilar products. |
Category 2: Registration of generic drugs and branded generic drugs. | ||
Category 3: Registration of other preparations containing drugs with special technology, can be in the form of transdermal patch, implant, and beads. | ||
Variation registration | Registration of changes in aspects of administration, efficacy, safety, quality, and/or product information and drug labels of drugs that have been granted marketing authorization in Indonesia | Category 4: Major variation registration that has a significant impact on the aspects of efficacy, safety, and/or quality of drugs. |
Category 5: Minor variation registration that does not belong to the category of major variation registration or notification variation registration. | ||
Category 6: Notification variation registration that has minimal or no impact at all on aspects of efficacy, safety, and/or quality of drugs, and does not change the information on the marketing authorization. | ||
Renewal registration | Registration of extension of the marketing authorization validity period | |
4. Registration Procedures
4.1 Pre-registration stage
Before entering the registration stage, the applicants should submit the pre-registration by filling out the application form in Indonesian or English.
The pre-registration is made for registration screening, including determining the registration category, the evaluation path, the evaluation fee, and the registration documents.
4.2 Registration stage
After being declared to have fulfiled the completeness of the documents, the applications will enter the evaluation by the Indonesian FDA.
The evaluation is an assessment of efficacy safety, quality, product information, and/or label in accordance with the criteria and categories of registration.
Fig 1: Drug Registration Procedures in Indonesia
4.3 Registration timeline
For pre-registration, the results will be published within 40 workdays (WD).
Evaluation timelines differ depending on registration categories and product types.
Table 3: Drug registration timeline in Indonesia
No. | Registration | Timeline |
a | Registration for export-only drug | 7 WD |
b | Renewal registration | 10 WD |
c | Minor variation registration | 40 WD |
d | First registration of IND by the pharmaceutical industry investing in Indonesia | 50 WD |
e | l The first registration of the first generic drugs by the pharmaceutical industry investing in Indonesia l Variation registration of new drugs and biological products related to quality that have been approved in at least one country with an established evaluation system | 75 WD |
d | 1) New registration of new drugs and biological products indicated for the treatment of serious diseases than threaten human life (lifesaving), and/or are easily transmitted to others, and/or there is no or lack of other safe and effective therapeutic options 2) New registration of new drugs and biological products based on justification indicated for serious and rare diseases (orphan drug) in Indonesia; 3) New registration of new drugs, biological products, generic drugs, and branded generic drugs is intended for national health programs equipped with supporting documents for program requirements or the results of prequalification of the WHO. 4) The first registration of new drugs and biological products by the pharmaceutical industry investing in Indonesia; 5) New registration of new drugs and biological products that have gone through the IND developed by a research institution or the pharmaceutical industry in Indonesia, made by the pharmaceutical industry in Indonesia and at least one clinical trial conducted in Indonesia; 6) New registration of generic drugs that have the same formulas, source of raw materials, drug specifications, quality, packaging specifications, manufacturing process, that have and use the same manufacturing facility as branded generic drugs that have been approved or vice versa; 7) Major variation registration with new indications/ posology for drugs intended as referred to in point 1) to point 5); 8) Major variation registration regarding quality and product information. | 100 WD |
g | l New registration of new drugs; l Major variation registration with new indications/posology that have been approved in at least one country with an established evaluation system | 120 WD |
h | l New registration of generic drugs; l Branded generic drugs that are not included in the evaluation path in point f | 150 WD |
i | l New registration of new drugs and biological products; l Major variations registration with new indications/posology that are not included in the evaluation as referred to in point d and point e | 300 WD |
Marketing authorization is valid for 5 years. Renewal registration should be submitted not sooner than 12 months and not later than 2 months before the expiration of the marketing authorization.
5. Special Requirements for Imported Drugs
For drugs imported into Indonesia, technology transfer must be carried out for the drugs to be manufactured locally. The technology recipient can be a foreign pharmaceutical company’s local affiliate in Indonesia, or other companies in Indonesia based on an agreement between the owner and the recipient of the technology.
6. Drug Registration Fee
In Indonesia, drug registration fees are regulated by the Government Regulation Number 32 of 2017 on Types and Tariffs of Non-Tax State Revenue Applicable to the Indonesia Food and Drug Authority.
Pre-registration is charged at Indonesian rupiah (IDR) 1 million per item, and a registration of drugs with new active substances, new biologics, and new combinations takes IDR 30 million per item.
The drug registration and evaluation fees are listed as follows:
Table 4: Drug registration fees in Indonesia
Non-tax revenue type | Unit | Rates (IDR) |
1. Registration, notification, and evaluation services | ||
a. Pre-registration | Per item | 1,000,000,000 |
b. Registration of drugs with new active substances, biological products, and new combinations | Per item | 30,000,000,000 |
c. Registration of new drugs or biological products registered with new indications, new dosage forms, new routes of administration, and/or new strengths | Per item | 20,000,000,000 |
d. Registration of new drugs or biological products with strengths, dosage forms, sizes, and/or types of packaging different from those of type b or type c | Per item | 7,500,000,000 |
e. Registration of generic drugs with trade names | Per item | 7,500,000,000 |
f. Registration of generic drugs with trade names and requiring clinical trials (including bioequivalence tests) | Per item | 12,500,000,000 |
g. Registration of generic drugs with trade names and with strengths, sizes and/or types of packaging different from those type f, and registered with type f | Per item | 7,500,000,000 |
h. Registration of generic drugs with generic names | Per item | 2,000,000,000 |
i. Registration of generic drugs with generic names and requiring clinical trials (including bioequivalence tests) | Per item | 7,000,000,000 |
j. Registration of generic drugs with generic names and with strengths, sizes, and/or types of packaging different from those of type i, and registered together with type i | Per item | 2,000,000,000 |
k. Registration of drugs with new combinations, new dosage forms, and/or new strengths that do not require the evaluation of clinical trial data | Per item | 7,500,000,000 |
l. Registration of variations that require the evaluation of quality, product information, and/or labeling that affects safety and requires clinical trial data | Per item | 12,500,000,000 |
m. Registration of variations to quality, production information, and/or with strengths, dosage forms, sizes or types of packaging different from those of type l, and register with type l | Per item | 2,000,000,000 |
n. Registration of drugs with trade names and with variations to manufacturers, manufacturing sites, and/or composition of active substances, and requiring clinical trial data (including bioequivalence tests) | Per item | 12,500,000,000 |
o. Registration of drugs with trade names and variations to registrants, manufacturers, manufacturing sites, and/or changes in the composition of active substances that do not require clinical trials | Per item | 7,500,000,000 |
p. Registration of drugs with generic names and with variations to manufacturers, manufacturing sites, and/or composition of active substances that affect safety and efficacy and require clinical trial data (including equivalence test) | Per item | 7,000,000,000 |
q. Registration of drugs with generic names and with variations to registrants, manufacturers, manufacturing sites, and/or changes in composition of active substance that does not require clinical trial data (including bioequivalence test) | Per item | 2,000,000,000 |
r. Registration of variations that require the evaluation of quality, product information, and/or labeling, and affect safety and efficacy | Per item | 2,000,000,000 |
s. Registration of variations that require the evaluation of quality, production information, and/or labeling, and do not affect safety or efficacy | Per item | 1,000,000,000 |
t. Renewal registration of drugs with trade names | Per item | 5,000,000,000 |
u. Renewal registration of drugs with generic names | Per item | 1,000,000,000 |
2. Drug evaluation services | ||
a. Evaluation of new drug applications | Per item | 10,000,000,000 |
b. Evaluation of clinical trial application for drugs | Per item | 5,000,000,000 |
c. Evaluation of bioequivalence test protocol applications | Per item | 2,500,000,000 |
d. Evaluation of requests for drug admission through a special pathway mechanism | Per item | 100,000,000 |
e. Evaluation of applications for drug advertising approval | Per version of ad for each product | 200,000,000 |
