The pharmaceutical market in Indonesia is currently valued at around $350 million. More than 50 percent of the market is comprised of imported products, with a large portion coming from the U.S., Germany, Switzerland and Japan. Foreign companies importing finished products or raw materials into Indonesia are required to obtain an import license from the Ministry of Health.
The National Agency of Drug and Food Control (NA-DFC) is responsible for ensuring the safety, quality and efficacy of pharmaceuticals in Indonesia. The NA-DFC also handles the Indonesia drug registration application review process, and grants drug approvals in the form of a marketing authorization license.
Indonesia Drug Registration Process
New Application vs. Variation Application
The Indonesian drug registration process is divided into two categories: (1) new drug applications and (2) drug variation applications. 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. A drug variation application is needed for drugs which have already been granted a marketing 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
The Indonesia drug registration process consists of two stages: (1) pre-registration and (2) submission of the registration dossier.
The pre-registration process is conducted to determine the application review and evaluation pathway. The NA-DFC reviews drug applications via one of three pathways (Path I, II or III). Path I includes drug applications for products used to treat serious or life-threatening diseases, or for essential generic drugs for public health programs. New drugs already approved in certain designated countries may qualify for the Path II registration process. 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:
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 produced for export-only are not required to have labels in Bahasa Indonesian; only English labels are required.
The following lists some of the documents and information required for the dossier:
- Good Manufacturing Practice (GMP) certificate
- Specifications and method of analysis
- Pharmacodynamic, pharmacokinetic and toxicity data
- Clinical trial report
- Labeling and packaging materials, including materials for the label, box, outer packaging, blister strip and catch cover
- Product insert/leaflet
- Product sample
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 resubmitting the dossier as a new Indonesia drug registration application.
If an application is reviewed by the NA-DFC and the NA-DFC decides that the product cannot be approved, the applicant has the option of submitting an appeal. The written appeal should be submitted within six months from the date of application rejection. The appeal should be accompanied by additional product data in order to better justify approval of the product. Applicants are allowed a maximum of two appeals.