Regulatory Services in Indonesia
Indonesia
The Indonesian authorities responsible for regulating drugs, biologicals, and medical devices are the Ministry of Health (MoH) and the Indonesia National Agency of Drug and Food Control (BPOM). The BPOM oversees the authorization of drugs and biologicals while the MoH regulates medical devices. Indonesian-based organizations can apply for marketing authorizations for medicinal products. The requirements for drug development and testing are different for generic versus new products. The BPOM accepts clinical and non-clinical trial results for new drug products that have been conducted overseas as part of marketing authorization procedure in Indonesia that is conducted online via the Risk-Based Approach Online Single Submission (RBA OSS) system. It is imperative for applicants to be registered in the RBA OSS system before they can be granted marketing authorization. This is also applicable to medical devices that are required to obtain Medical Devices Manufacturing Certificate for local manufacturers, or Medical Devices Distribution Certification for importers.
As a leading global contender, DDReg’s regulatory services in Indonesia provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Experts Reports
- IPR Support, including Worldwide Patent Status and Patent Reviews