Pharmaceuticals Regulatory Affairs Consultant in Indonesia

Expert pharmaceutical regulatory affairs and compliance support in Indonesia, from BPOM drug registration and import licensing to post-approval obligations.

Pharmaceuticals

Pharmaceutical Regulatory Affairs Services in Indonesia

The Indonesian pharmaceutical market is experiencing growth with a 4.77% annual growth rate and a large pharmaceutical market in South-East Asian nations. Our regulatory experts have excellence in the regional regulatory framework of pharmaceuticals in Indonesia, regulated by National Agency of Drug and Food Control (NADFC) also called as Badan Pengawas Obat dan Makanan (BPOM). Artxio’s team offers comprehensive support for market approval, regulatory insights throughout product development and accelerated successful approval launching.

Pharmaceutical Regulations in Indonesia

In Indonesia pharmaceutical is regulated under the BPOM Regulation No. 1020/MENKES/PER/XII/2008 for registration process requirements. Indonesia is member of ASEAN (Association South-East Asian Nations) registration application must submit in ACTD format through Online Single Submission (OSS).

Classification of registration applications

Pharma Product Registration Procedure in Indonesia

Registration of Pharmaceutical Products Consists of Two Stages

Pre-registration Stage – Pre-registration stage includes establishing evaluation pathway and registration fee, screening of documents.

Pre-Registration Evaluation Will Be Done Within 40 Working Days

Registration Stage – After evaluation and approval of pre-registration stage application further review for quality, safety, efficacy, and labeling information in registration phase. Timeline depends on approval pathway.

Indonesian Registration Approval for Pharma

Full Application Pathways

Abridged Evaluation Pathways

Special Approval Pathways

Artixio’s Pharma Regulatory Affairs Services in Indonesia

Why Choose Artixio For Pharmaceutical RA Services in Indonesia?

FAQs

How to manage different post approval changes in Indonesia?

As per BPOM regulation post approval changes categorise as follows-

Sr. No.	Variation Category	Description	Timeline
1	Major Variation (VaMa)	Changes with significant impact on efficacy, safety, or quality. Prior approval required.	Varies (100-300) WD
2	Minor Variation (VaMi-B)	Minimal effects on quality of product that requires prior approval.	40 WD
3	Minor Variation (VaMi-A)	No effects on quality, safety of product. No prior approval requirement, need to submit notification.	—

Can foreign manufacturer launch pharmaceutical product in Indonesia market?

As per BPOM, only local pharmaceutical company can import the pharmaceutical drug product in Indonesia, to launch the drug product foreign company requires pharmaceutical license of local company.

What is the validity of pharmaceutical license in Indonesia?

Pharmaceutical license is valid for 5 yeas from the date
of Marketing authorization issued by BPOM.

Which are the reference countries BPOM accepts data for Abridged evaluation?

US-FDA, EU-EMA, Japan-PMDA, Canada-Health Canada, Australia- TGA and other ASEAN countries accepted as reference countries.

Pharmaceuticals Regulatory Affairs Consultant in Indonesia