Three formats cover almost every market a generic exporter from India will meet. The ICH CTD, in five modules, is the default — Nigeria’s NAFDAC has adopted it, and so have India, the EU, the US, Japan, Canada and most WHO-aligned regulators. The ASEAN ACTD reorganises the same evidence into four parts. A smaller group of regulators still runs a format of its own. The evidence barely changes between them. Where it sits changes completely, and that is where dossiers lose months.
The same evidence, three different shelves
The ICH CTD has five modules. Module 1 is regional administrative information — application forms, labelling, product information, local fees — and is deliberately not part of the harmonised CTD, which is why it differs in every country. Module 2 holds the summaries and overviews. Module 3 is quality. Module 4 is nonclinical study reports. Module 5 is clinical study reports. ICH M4Q is the guideline that governs Module 2.3 (the Quality Overall Summary) and the whole of Module 3.
The ASEAN ACTD (Revision 1) has four parts: Part I administrative and product information, Part II quality, Part III nonclinical, Part IV clinical. These map to CTD Modules 1, 3, 4 and 5. There is no ACTD part corresponding to Module 2 — the summaries sit inside their own parts instead. Part II opens with Section A (table of contents), Section B (the Quality Overall Summary) and Section C (Body of Data: drug substance first, then drug product), closing with Section D for key literature references.
For a generic application the ACTD is explicit that “the documentation of this part is not required for Generic Products, Minor Variation Products and some Major Variation Products” — that applies to Parts III and IV.
One conversion trap is worth naming, because it catches people who assume the two formats are a relabelling exercise. The ACTD’s drug product section runs to P9, Product Interchangeability — bioequivalence data sits inside the quality part. In the CTD, bioequivalence goes to Module 5. Convert an ACTD to a CTD by renaming folders and the BE study ends up in the wrong module.
What Module 3 actually needs from the manufacturing site
Regulatory affairs can write the overviews. Module 3 has to come out of the plant, and the list is fairly fixed:
• The batch formula, and the manufacturing site name, address and licence number exactly as they appear on the manufacturing licence
• A process flow chart plus a narrative description with equipment class, batch size range and critical process parameters — not equipment brand names, but not “as per SOP” either
• In-process control tests with numerical limits and the stage at which each is applied
• Batch analysis data on production-scale batches, with the analytical procedures and their validation
• Excipient specifications, supplier certificates of analysis and the source declaration for anything of animal origin
• Container-closure system specification, including foil and film grades and dimensional drawings
• Stability data on the exact pack offered
On stability, the WHO conditions are the ones to work to. Accelerated testing runs at 40 °C ± 2 °C / 75% RH ± 5% RH for at least six months. Long-term testing for hot climates is at 30 °C / 65% RH (Zone IVa) or 30 °C / 75% RH (Zone IVb) — Nigeria is Zone IVB. A minimum of 12 months of long-term data is expected at submission where the proposed shelf life is 12 months or more. Confirm which Zone IV condition your destination regulator wants before you put a chamber on it; the two are not interchangeable.
The two sections that generate the most rework
This is not a matter of opinion. WHO Prequalification published a list of common deficiencies found in finished pharmaceutical product dossiers (WHO/PQT: medicines, 27 February 2018), with figures drawn from its own assessment record. Two clusters dominate.
3.2.S — the drug substance section. “In 35% of the reviewed dossiers missing or inadequate control of polymorph identity and/or PSD were noted.” The other recurring findings are an API specification that does not match the API manufacturer’s own approved specification, and limits for unspecified impurities set wider than the ICH Q3A/Q3B identification threshold. Almost all of this depends on what the API supplier will actually put in writing, which is why it stalls.
3.2.P.2 and 3.2.P.3 — pharmaceutical development and the process description. “Inadequate or poorly defined end point for wet granulation process affected about 50% of the reviewed dossiers.” WHO is direct about the language: “statements such as ‘stop granulation when required consistency is achieved’ are not acceptable.” Missing hold-time justification and missing multimedia dissolution profiles on the biobatch appear repeatedly. Related, and larger still: “about 60% of the reviewed applications had protocols deficient” on process validation, including failure to validate a compression machine speed range.
The uncomfortable part is that both clusters are things the factory already knows and the file simply does not say. They are documentation failures, not manufacturing failures — which is why they are cheap to prevent and expensive to answer.
Which market wants which
| Authority / market | Format | What to watch |
| NAFDAC (Nigeria) | CTD, adopted through the ICH process | Zone IVB stability; country-specific Module 1 |
| CDSCO (India) | CTD | Domestic Module 1 requirements differ from export files |
| ASEAN members (e.g. Malaysia) | ACTD | Part II P9 interchangeability; no Module 2 equivalent |
| Singapore | ACTD or CTD accepted | Choose one and be consistent across the file |
| NMRA (Sri Lanka) | Country-specific format (see below) | Verify current guidance before compiling |
| WHO Prequalification | CTD | Deficiency list above is published — read it first |
“Country format” is not a lesser format
A 2018 comparative study in the Journal of Pharmaceutical Policy and Practice examined ten regulators and found Sri Lanka using “a format which it had developed based on the WHO recommendations for drug registration but not claimed to be either ICH:CTD or ACTD,” covering 79 of the 126 criteria WHO recommends. The same study found that nine of the ten authorities had mandated review timelines and Sri Lanka did not — yet its median approval time across eight audited generic dossiers was 90 working days, with a range of 7 to 379 days. Fewer stated criteria did not mean a slower or softer review; it meant a less predictable one.
Two things are in motion. ASEAN regulators are moving toward electronic submission, and ICH M4Q itself is under major revision — M4Q(R2) reached Step 2b with public consultation running from 25 June to 24 October 2025. Anything written about format today should be re-checked against the regulator’s own current guidance page before a file is built on it.
How Salus approaches this
Salus Pharmaceuticals manufactures formulations at its WHO-GMP and ISO 9001:2015 certified facility in Baddi, Himachal Pradesh, and has done since 2005. Module 3 inputs — batch formula, process description, in-process controls, batch analysis, container-closure specification and pack-specific stability — are compiled from the site’s own records for the pack and market the buyer is registering, and Salus currently supplies markets including Nigeria, Bangladesh and Sri Lanka.
Tell us the destination regulator and the pack you intend to register, and we will tell you which Module 3 inputs we can supply and what has to come from the API manufacturer.
[Enquire about dossier support →]
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