Clinical Trial Data Requirements
All clinical trials phases I to III must follow Good Clinical Practices (GCP) standards. An application form (UK-1) should be submitted with a research protocol, approval from the ethics committee and scientific committee, investigator's brochure, and the amount of drug needed for a trial. If the clinical trial application is approved by the NA-DFC, an approval letter and drug import license will be sent to the investigator within 10 working days. More information is available in the Indonesian Guidelines for GCP.
Clinical Trial Import Authorization
Import authorization is granted after clinical trial application approval.
Clinical Trial Estimated Timeline
10 working days.
In-Country Manufacturing Requirements
Under Ministry of Health Decree No. 1010/2008, foreign pharmaceutical companies are required to locally manufacture a pharmaceutical or partner with an existing local manufacturer to receive drug approval. Products that have been off patent for five years are exempted from this requirement.
Informed consent should include a description of compensation and/or treatment available to a subject in the event of a trial-related injury. Section 5.8 of Indonesia's Good Clinical Practices outlines compensation requirements to subjects. The sponsor should address the cost of treatment to participants in the event of injuries that are related to the trial.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
8 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
Product registration is a two part process, outlined in Regulation No. HK.03.1.23.10.11.08481 (2011). The pre-registration process is a screening that determines the registration category of the product, product evaluation point, evaluation cost, and necessary registration documents. Within 40 working days, the applicant should receive a letter from the Head of Agency on the pre-registration. This letter is valid for one year. If requested, the applicant has 20 days to submit additional data.
Application for new registration involves a separate form and support documents.
The registration dossier format is aligned with the ASEAN CTD (Part I: Administrative Documents, Product Information, Labeling; Part II: Quality; Part III: Non-clinical; Part IV: Clinical). More specific information is listed in Regulation No. HK.03.1.23.10.11.08481.
Product Registration Estimated Timeline
Estimated timelines are listed in Regulation No. HK.03.1.23.10.11.08481 (2011).
The pre-registration phase takes 40 working days. Following pre-registration, the amount of time it will take to register a product depends on product type and indication.
40 working days:
a. Registration of minor variations that required approval
b. Registration of Drug for Export.
100 working days:
a. New Registration of New Drugs and Biological Products indicated for the treatment of serious diseases threatening human life (life saving), and/or easily transmitted to others, and/or there is no or less other therapies that are safe and effective
b. New Registration of New Drugs and Biological Products based on justification is indicated for serious and rare diseases (orphan drug)
c. New Registration of New Drugs and Biological Products intended for public health programs
d. New Registration of New Drugs and Biological Products that have been through the process of developing a new drug developed by the pharmaceutical industry or research institutions in Indonesia and all phases of clinical trials conducted in Indonesia
e. New Registration of essential generic copy drugs that come with supporting documents of program required or supporting data as essential drugs
f. New Registration of Copy Drug with standard electronic information (Stinel)
g. Register of new indications/posology major variation for drugs aimed to as intended in paragraphs a, b, c, and d
h. Registration of major variations is not included in the paragraph g.
150 working days:
a. New Registration of New Drugs, Biological Products, and major variations registration in new indications/posology which has been approved in countries that have adopted a harmonized evaluation system and in countries with well known evaluation system
b. New Registration of New Drugs, Biological Products, and major variations registration in new indications/posology which has been approved in at least three (3) countries with well known evaluation system
c. New Registration of Copy Drug without Stinel
300 working days:
a. New registration of New Drugs, Biological Products, similar Biological Products, or registration of major variations of new indications/posology that are not included above
Product Registration Costs
According to "Regulatory Environment and Clinical Trials in Southeast Asia," 20 million Rupiah (about 200 USD)
Product Registration Process for Products Approved by SRA/WHO
Registration process takes 150 working days for products that have been approved by a SRA.
Post Registration Pharmacovigilance Requirements
An overview of pharmacovigilance in Indonesia is available here. Pharmacovigilance regulations are outlined in MoH Regulation No. 1799/Menkes/Per/XII/2010 on Pharmaceutical Industry, Article No. 9 and NA-DFC Regulation No. HK.03.1.23.12.11.10690/2011 on Implementation of Pharmacovigilance for Pharmaceutical Industry.
USAID/SIAPS conducted a comparative analysis of pharmacovigilance in five asian countries, including an overview of the pharmacovigilance system in Indonesia. The report is available here.
Post Registration Labeling Requirements
Indonesia follows ASEAN's labeling requirements, which is available here. The guidelines additionally outline specific labelling requirements for Indonesia.
January 14, 2016.