Drug Registration Process In Indonesia
The pharmaceutical market in Indonesia ranks the largest market in the ASEAN regions, with the market value expected to hit IDR 141.6 billion (USD 10.11 billion) by 2021. There is a steep increase in the number of drug registrations in Indonesia due to the huge market size and regulatory advantages over other countries.
Key highlights of Indonesia’s drug market
- Large population.
- Increase government healthcare spending.
- Good Over-the-counter (OTC) market: OTC products category amount to IDR 48.8 trillion (USD 3,483 million) in 2018 and is expected to grow by 1.3% per year.
- The Indonesian Pharmacists Association reports that Indonesia imports about 95 percent of raw material for medicine.
- There is an increase n the foreign ownership of pharmaceutical firms from 75 to 100 percent.
- An increase in chronic illnesses and the growing spending power of the middle class are the factors for greater demand.
- 75% of drug needs are met by domestic players, and the remaining 25% are fulfilled by foreign companies.
- Increased government support: The government modified the law with the previous partially foreign ownership to the current 100% full foreign ownership.
Last five years statistics
Here is the number of products registered in various categories in the last five years.
- 4,657 Food supplements
- 12,216 Traditional medicines
- 18,601 Drugs
- 182,452 Cosmetics
This shows the quick regulatory landscape for drugs and cosmetic products.
Drug regulatory authority in Indonesia
The National Agency of Drug and Food Control (NA-DFC) is the regulatory authority responsible for ensuring the safety, quality, and efficacy of pharmaceuticals in Indonesia.
The NA-DFC oversees the drug registration application review process and grants drug approvals in the form of a marketing authorization license.
Criteria of drug evaluation
- The regulatory authority evaluates the drugs in Indonesia based on risk assessment.
- The applicants need to establish the efficacy and safety of non-clinical studies and clinical studies for phases I, II, III.
Quality, Safety And Liability requirements
- To support the quality of the drug, the applicant needs to provide the drug master file for new chemical entities, first generic drugs, and generics drugs for life-saving and serious illnesses, such as cancer, cardiovascular diseases, and antibiotic drugs.
- Also, conducts on-site evaluation at the facility of the product manufacturer to ensure the validity of information written in documents of quality.
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The drug registration in Indonesia
The Indonesian drug registration process is broadly divided into three categories
- New drug registration
- Drug variation registration
Let’s discuss it one by one briefly.
New drug registration
A new drug application is required for the following types of products or product changes:
- A new active ingredient,
- A new derivative or combination, or
- A new dosage form, strength, or indication.
Based on Article 5 (2) of the drug registration regulations, the type of new registration is further classified into three categories
- Category 1: Registration of new drugs, biological products, including similar biotherapeutic products.
- Category 2: Registration of copy drugs.
- Category 3: Registration of other supplies which contain drugs.
Drug variation registration
For the dugs which have market authorization license, but have undergone a modification of one of the following.
- Trade name
- Manufacturing site or factory name
- Inactive ingredient
- Method of analysis
- Packaging or labeling
Based on Article 5 (3) of the drug registration regulations, the type of Variation registration is further divided into these categories
- Category 4 (VaMa): Registration of major changes of the registered drugs’ information (i.e., Variation Registration which has a meaningful impact on the efficacy, safety, and/or quality of the drugs) (variasi major or “VaMa”).
- Category 5 (VaMi-B): Registration of minor changes of the registered drugs’ information which still requires approval, i.e., Variation Registration which cannot be categorized under VaMi-A or VaMa (variasi minor yang memerlukan persetujuan or “VaMi-B”).
- Category 6 (VaMi-A): Registration of minor variation on drugs which only need to be notified to BPOM, i.e., Variation Registration which has a minimal impact or none at all to the efficacy, safety and/or quality of the drugs, and does not change the information in the marketing authorization (variasi minor dengan notifikasi or “VaMi-A”).
- Based on Article 5 (4) of the Drug Registration Regulations, Re-Registration is a Category 7 registration.
- This category includes renewal or extension of the marketing authorization period.
Regulatory steps for registration
The Indonesia drug registration process consists of two steps
- Submission of the registration dossier
The pre-registration process is conducted to determine the application review and evaluation pathway.
NA-DFC reviews drug applications via one of three pathways (Path I, II, or III).
- The Path I include drug applications for products used to treat serious or life-threatening diseases.
- Path II registration process new drugs already approved in certain designated countries.
- Any drug applications for products that do not qualify for Path I or Path II evaluation processes will be reviewed via the Path III process.
Generally, applications are review within the following timeframes
- The Path I: 100 working days
- Path II: 150 working days
- Path III: 300 working days for new drugs; for all other drugs, 80 working days
Registration dossier requirements
Marketing authorization licenses are valid for five years in Indonesia.
The Indonesia drug registration forms and accompanying documents can be in Bahasa Indonesian or English. Drugs manufactured for export-only are not required to have labels in Bahasa Indonesian; English labels are sufficient.
- The head of the NA-DFC is responsible for issuing the marketing authorization approval/non-approval decision.
- In some cases, the NA-DFC may request additional data in order to determine the product approval/non-approval. In this situation, the applicant will have 120 days to submit this requested information.
- If the applicant is unable to provide the data within the given timeframe, the application will be rejected.
- However, the applicant has the option of submitting the dossier as a new Indonesia drug registration application.
In cases where the NA-DFC reviews the application and decides to disapprove the product, the applicant has the option to submit an appeal.
The applicant can submit a written appeal within six months from the date of application of rejection. The appeal should be accompanied by additional product data to better justify approval of the product.
Applicants are allowed a maximum of two appeals.
Timeline for evaluation
- 40 working days for export-only products and for minor variations that need to be approved.
- 100 working days for life-saving drugs, orphan drugs, drugs for national programs, drug development and all clinical trials in Indonesia, and generic drugs with electronic standardized information.
- 150 working days for drugs that have been marketed in countries that have implemented harmonized evaluation systems.
- 300 working days for new drugs, biological products, and similar biotherapeutic products not included in the list of 100 working days and 150 working days.
Authorizations, variations, and renewals
- The authorization is valid as long as the pharmaceutical manufacturer continues production and complies with the relevant laws and regulations.
- A pharmaceutical manufacturing authorization includes an authorization to manufacture drugs and/or medicinal substances.
- The applicant shall submit all the changes to the director-general of pharmaceuticals at the Ministry of Health.
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