Everyone loves to say ASEAN is harmonised. Say that to a regulatory team holding a flawless ACTD dossier that one country wants filed through a local licence holder, another wants tied to a License to Operate, and a third wants repackaged for a different portal. Harmonised format, yes. Harmonised approval, not even close.
This is Article 1 of a new series that will take pharmaceutical registration apart region by region: forms, documents, submission routes and approval procedure, for generics, biosimilars, medical devices and every dosage form from tablets to injectables. We start where the volume is: regular generic dosage forms across ASEAN.
1. What ASEAN actually harmonised
The ASEAN Common Technical Dossier (ACTD) and the ASEAN Common Technical Requirements (ACTR) were adopted and adapted from ICH. That is the real achievement: one table of contents that regulators across the region understand. It is a format, not a passport.
| ACTD part | Content | For a generic |
| Part I | Administrative data and product information (forms, CPP, GMP, labelling, leaflet) | Required, and the most country specific part |
| Part II | Quality: Part S for drug substance, Part P for drug product | Required, the heart of the file |
| Part III | Safety (nonclinical) | Not required for generics |
| Part IV | Efficacy (clinical) | Bioequivalence evidence where applicable |
Around the dossier, ASEAN built four tools worth knowing:
- Stability guideline. Long term testing in the region is set at Zone IVb, 30 C and 75 percent relative humidity. Data generated only for temperate zones will get you questions.
- Bioequivalence MRA. NPRA Malaysia states it accepts bioequivalence studies from centres listed under the ASEAN mutual recognition arrangement.
- GMP MRA. A sectoral arrangement so countries can lean on each other’s inspections of manufacturers.
- Joint Assessment. A pilot that began in July 2017, where one application is assessed by several regulators together.
2. The six pillars of every ASEAN generic file
| Pillar | What the regulators want |
| 1. Local legal entity | A licensed local holder files and owns the registration. Foreign manufacturers cannot file directly in Thailand, and Indonesia and the Philippines work the same way. |
| 2. GMP proof | Site GMP certificate, Certificate of Pharmaceutical Product (CPP) and free sale certificate. Singapore now also wants GMP compliance evidence for drug substance manufacturers. |
| 3. Bioequivalence | A study per ASEAN guidance for immediate release oral solids, ideally at a listed centre. |
| 4. Stability at Zone IVb | Long term 30 C and 75 percent relative humidity, with accelerated data. |
| 5. Local labelling | Artwork, language and leaflet content that match national rules. Labelling errors are a classic delay in Thailand. |
| 6. Samples and permits | Malaysia asks for samples within 14 working days of screening approval. Laos wants a sample import permit before the certificate. |
3. The universal pathway in eight moves
| 1. Classify the product and confirm the reference product | ▶ | 2. Appoint the local holder | ▶ | 3. Build the ACTD: Parts I, II and BE | ▶ | 4. Collect CPP, GMP, free sale, authorisation letters |
| 8. Certificate, then labelling, pharmacovigilance, renewal | ◀ | 7. Answer evaluation queries | ◀ | 6. Screening for completeness | ◀ | 5. Submit through the national portal |
4. Country by country
Malaysia: NPRA and the Drug Control Authority
NPRA evaluates and the Drug Control Authority decides. Everything runs through the QUEST 3+ portal, which needs a token. Classify first: generics sit in their own category, and the category sets your fees and evaluation route. Generics need patent declarations from the Product Registration Holder. For a second source immediate release oral solid, the bioequivalence report must come from the actual manufacturing site, unless the exemption conditions are met: the first source product was evaluated by NPRA with a satisfactory study, and the second source matches it in formulation and the other listed attributes. The published full evaluation target for prescription drugs is 210 working days. Consultants quote 12 to 24 months in practice. Plan for the second number.
Singapore: HSA and PRISM
The Generic Drug Application splits into GDA 1 for the first strength and GDA 2 for later strengths, and the product must be essentially the same as the Singapore reference product. HSA publishes checklists for both ICH CTD and ACTD. You file in PRISM and send the dossier within 2 working days. The screening target is 50 working days and the GDA abridged evaluation target is 150 working days, with a shorter verification route for eligible products. Dossiers and drug master files move through the EasiShare cloud platform, and Swissmedic has joined the list of reference agencies.
Thailand: Thai FDA
No local holder, no filing. Thailand also layers an import licence on top of product registration, so you need both the business licence and the product approval. ACTD or ICH CTD are accepted, and new drug applications are now electronic. The Thai FDA separates a “new generic” (the first generic of a patented originator) from a “generic”, and the first one carries heavier bioequivalence and patent detail. The FDA’s service manual quotes about 280 working days for new drug registration. Consultants quote 6 to 12 months for generics, while older legal commentary puts new generics near two years. That spread is the warning: build slack into the plan.
Indonesia: BPOM, and halal on top
A foreign brand registers through a local license holder, and the marketing authorisation carries a BPOM number (prefixes such as DK, DBL, DTL, GKL for pharmaceuticals). The twist is halal. Government Regulation 42 of 2024 phases mandatory halal certification by product class:
| Product class | Halal deadline |
| Natural drugs, quasi drugs, health supplements | 17 October 2026 (just passed) |
| Over the counter drugs | 17 October 2029 |
| Prescription drugs (excluding psychotropics) | 17 October 2034 |
Products made from non halal materials need no certificate, but they must be labelled as non halal. Foreign halal certificates from recognised bodies can go through the SHLN registration route instead of a full local audit. Prescription generics have until 2034, but formulation and excipient choices made today decide whether you ever need that certificate.
Philippines: FDA Philippines, CDRR
First a License to Operate, then a Certificate of Product Registration (CPR) for each product. ACTD is mandatory and filing is through the FDA eServices portal. You choose 2 or 5 year CPR validity, with fees scaling accordingly, and branded generics also need brand name clearance. A risk management plan for a generic is requested only case by case. Dangerous drugs carry extra requirements tied to the drug enforcement authorities. Eligible products can use an abridged or verification pathway based on reliance on trusted regulators, and the Philippines takes part in ASEAN Joint Assessment.
Vietnam: Drug Administration of Vietnam
The rulebook just changed. Circular 32 of 2026 from the Ministry of Health took effect on 1 October 2026, replacing Circular 12 of 2025. Foreign legal documents can now skip consular legalisation when DAV can verify them directly through official electronic means, including confirmation sent by the foreign authority or public English language databases of recognised regulators. After a refusal on a new registration, renewal or variation, applicants get one month to submit a written request for reconsideration. Anyone running a Vietnam file prepared before October should recheck the document list.
The smaller regimes: Brunei, Cambodia, Laos, Myanmar
Brunei. Registration falls under the Medicines Order 2007, administered by BDMCA, with ACTD format and a local representative, sole agent or appointed pharmacist as applicant. Cambodia. The Department of Drugs and Food runs the CamPORS online system, accepts ACTD, and asks for a local authorised representative plus CoPP, GMP certificate and free sale certificate. A consultancy reports 3 year registration validity. Laos. The Food and Drug Department works through a local representative or licensed company, has moved to a new online registration system, and grants sample import permission before issuing the certificate. Myanmar. Public guidance is thin, so confirm requirements directly with Myanmar FDA before you commit a budget.
5. The comparison table
| Country | Regulator | Format and system | Local presence | Watch point |
| Brunei | BDMCA | ACTD, BDMCA forms | Representative, agent or appointed pharmacist | Medicines Order 2007 |
| Cambodia | Dept of Drugs and Food | ACTD, CamPORS | Authorised representative | CoPP, GMP, free sale |
| Indonesia | BPOM | ACTD for generics | Local license holder | Halal phases to 2034 |
| Laos | Food and Drug Dept | ACTD based, online | Representative or licensed company | Sample import permit |
| Malaysia | NPRA and DCA | ACTD, QUEST 3+ | Product Registration Holder | Site specific BE report |
| Myanmar | Myanmar FDA | ACTD based | Confirm with FDA | Thin public guidance |
| Philippines | FDA, CDRR | ACTD, eServices | Local entity with LTO | 2 or 5 year CPR |
| Singapore | HSA | ICH CTD or ACTD, PRISM | Local registrant | GDA 1 and GDA 2 |
| Thailand | Thai FDA | ACTD or CTD | Licensed holder, compulsory | Import licence too |
| Vietnam | DAV | ACTD for generics | Check Circular 32 text | New rules since 1 Oct 2026 |
| Published timeline signals (targets, not promises) | Figure |
| Malaysia, full evaluation, prescription drugs | 210 working days |
| Singapore, GDA abridged route, evaluation | 150 working days after 50 days screening |
| Thailand, new drug per FDA service manual | About 280 working days |
| Philippines, abridged route (consultancy figure) | 30 to 45 days |
6. Joint Assessment: the shortcut that isn’t one yet
ASEAN Joint Assessment means the same application goes to all participating regulators at the same time, they assess it together and produce one joint report. A joint assessment needs at least three regulators. There is a full route and an expedited route that leans on a reference regulator or WHO prequalification. Participation is voluntary product by product, and the shared platform is limited to the countries that join.
7. The mistakes that quietly kill timelines
- Treating ACTD as a passport. Part I is where countries diverge.
- Late legalisation. CPP, GMP and free sale certificates are slow. Start them before the dossier is done.
- Bioequivalence at the wrong place. An unlisted centre or a non site specific study creates avoidable queries.
- Stability for the wrong climate. Zone IVb is the regional standard.
- Name mismatches. Character level differences between certificates, invoices and dossiers trigger rejections in Indonesia’s halal system.
- Ignoring the day after approval. Labelling, pharmacovigilance and renewal clocks start immediately.
8. A sensible filing strategy
Build one master ACTD with Zone IVb stability and a bioequivalence package from a listed centre. File Singapore and Malaysia first, because their reviews are the most structured and their approvals strengthen later files. Run the Philippines, Thailand, Indonesia and Vietnam in parallel through local holders. Handle the smaller markets through partners who live inside those systems. This sequence is a judgement call, not a rule, and your product, patents and reference product status can change it.
Coming next in the series
Same war, new battlefield. The series continues with other regions and other product types, including biosimilars, medical devices and the harder dosage forms.
References
- ASEAN Secretariat, ASEAN Common Technical Dossier (ACTD) Rev. 1, Table of Contents and Organization of the Dossier
- ASEAN Guideline on Stability Study of Drug Product, Version 6.0
- ASEAN Secretariat, ASEAN Joint Assessment Procedure for Pharmaceutical Products, Information for Applicants and FAQ (2022), and NPRA Malaysia FAQ Revision 3
- DIA Global Forum, Joint Assessment of Marketing Authorization Applications, September 2021
- EFPIA, Position paper on the WHO ASEAN Joint Assessment
- NPRA Malaysia, Product Registration Process and Drug Registration Guidance Document pages
- Conventus Law, Entering the Malaysian Pharmaceutical Market, a step by step guide
- Health Sciences Authority Singapore, Appendix 5 Target Processing Timeline, and Reclassification application guidance
- Baker McKenzie, Singapore regulatory updates for therapeutic product registration, August 2024, and Therapeutic Products flyer 2025
- Lexbangkok, Drug Registration in Thailand: A 2026 Guide to Thai FDA Approval
- Maven Regulatory Solutions, Thai FDA pharmaceutical regulations guide, January 2026, and Philippines generic registration article, May 2026
- Tilleke & Gibbins, Thailand’s approach to patent expiry and generic approval; Foreign Halal Certificate Registration in Indonesia; Vietnam’s New Drug Registration Regulations to Reduce Administrative Burden, 10 August 2026
- Mondaq, Vietnam’s New Drug Registration Regulations To Reduce Administrative Burden, 11 August 2026
- Freyr Solutions, Generic Drug Registration Philippines, and Mandatory Halal Certification 2026: 7 Key FAQs
- FDA Philippines, Citizen’s Charter checklist for initial registration of prescription generic drugs
- Emerhub, Halal Certification in Indonesia and BPOM registration resources
- Brunei Ministry of Health, Guide to Application for Registration of Medicinal Products, 4th edition
- Cambodia Department of Drugs and Food, Guidelines on Registration of Therapeutic Product in Cambodia (2019); OMC Medical, Cambodia and Laos drug registration pages
- DDReg Pharma, Malaysia pharmaceutical regulatory pathway resources
- ASEAN Magazine and national press coverage of the admission of Timor Leste, 26 October 2025
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