GOVERNANCE · TEMPLATES & MONITORINGSYNTHETIC DATARA LEAD · DRUG
Templates & Regulatory Monitoring
The dossier index templates that drive compilation, and the guideline movement that revises them.
Dossier Index Templates
One template per activity per market per product category — new and renewal share a template only where the guideline is identical. A revision becomes usable in live projects the moment the department head approves it.
TEMPLATE
REV
DOC ROWS
RELEASED BY
STATE
Peru — New Drug Registration
Ethical drug · new
Rev 8
176 rows
Pending · Nita Deshpande
PENDING
Peru — Food Supplement
New and renewal share one guideline
Rev 3
88 rows
Released · Nita Deshpande
LIVE
Vietnam — New Registration
Ethical drug · new
Rev 6
318 rows
Released · RA head
LIVE
Vietnam — Biosimilar
Biologic · own guideline
Rev 2
246 rows
Released · RA head
LIVE
Vietnam — Cosmetic Notification
New and renewal · Thailand division
Rev 4
42 rows
Released · Thailand RA
LIVE
ACTD Common Parts
Shared index across ASEAN
Rev 5
204 rows
Released · RA head
LIVE
Ethiopia — National Permit
Ethical drug · new
Rev 0
164 rows
Released 25 Jan 2016 · N. Deshpande
STALE
PERU NRA
15 SEP 2026
National checklist reissued with three added annexes
Peru new drug registration moves to Rev 8; one live run picks up the annexes once approved.
PE — New Drug Registration Rev 8
VIETNAM NRA
01 OCT 2026
Stability expectations restated for Zone 4B submissions
Two ACTD runs cannot be accepted without the Zone 4B set.
VN — New Registration Rev 6VN — Variation Rev 3
ETHIOPIA NRA
TBC
Certified translation requirement clarified for permit annexes
Machine drafts are not submittable; the certified route is enforced in language versions.
ET — National Permit Rev 0
PHILIPPINES NRA
20 AUG 2026
Letter of access format updated for local agents
Template regenerated; one open filing affected.
PH — New Registration Rev 5
Template Revision History
Every revision carries a reason, an approver and the live projects it was pushed into. Nothing is edited in place.
REVISION
REASON
APPROVER
DATE
PUSHED TO
PH-GEN-NEW
r7 · proposed
National checklist reissued: raw batch data now required in place of the batch summary.
N. Deshpande
14 Aug 26
HELD
VN-GEN-NEW
r5 · released
Certified translation scope narrowed to artwork and pack insert only.
N. Deshpande
02 Jul 26
4 PROJECTS
VN-GEN-REN
r3 · released
Renewal split from the new-registration template — the guideline diverged.
R. Menon
19 Jun 26
2 PROJECTS
PE-GEN-NEW
r4 · released
Part I resubmission format changed; annexe order fixed by the authority.
N. Deshpande
28 May 26
1 PROJECT
ET-GEN-NEW
r2 · proposed
GMP certificate scope wording tightened after two round-one deficiencies.
unassigned
11 Aug 26
HELD
MM-GEN-VAR
r1 · draft
First variation template for this market; drafted from three past filings.
—
18 Aug 26
DRAFT
Checklist Rows · Philippines NRA, generic new registration
The template is a document list, not prose. Each row states who owns it, whether it repeats, and what blocks it.
I · 1Application form and covering letterGenerated from the market profile; local agent block required.ONCE
I · 4Certificate of pharmaceutical productLegalised original. Apostille page linked to the certificate.ONCE
II · SDrug substance sectionRepeats per active ingredient and per approved API supplier.REPEATS
II · P.3Batch manufacturing recordsRaw batch data required — the summary is not accepted here.PER BATCH
II · P.7Container closure systemOne row per packaging configuration; each is its own registration.PER PACK
II · P.8Stability dataZone 4B, minimum six months accelerated plus twelve long term.ONCE
III · 1Artwork and pack insertCertified local-language version, signed by a qualified expert.PER PACK
Revision Diff · PH-GEN-NEW r6 → r7
What the monitoring agent found, what it proposes, and what a human still has to accept.
+II · P.3 — raw batch dataNew required row. Batch summary moves to supporting, no longer sufficient on its own.
−II · P.3 — batch summary (required)Downgraded to optional. Existing runs that used it are flagged, not failed.
~III · 1 — artworkWording of the expert certification statement updated by the authority.
~I · 4 — CPPValidity window shortened from 24 to 18 months from issue.
!Affects 1 live projectZenaflozin 10 mg Philippines is mid-compilation against r6.
Held for approval by Nita Deshpande. Until she releases r7, live Philippines projects continue to compile against r6.
Recognised Standards Check
A standards body publishing a new revision is not, by itself, a reason to touch a dossier. The platform checks the receiving authority's recognised-standards list first: if the authority has not adopted the revision, nothing changes and the file says so. This is the step that stops the system generating work nobody owes.
STANDARD
PUBLISHED
AUTHORITY POSITION
CONSEQUENCE
Stability testing guideline
Climatic zone conditions and storage claims
Mar 2026
Vietnam NRA
Adopted in full from Jan 2027
TEMPLATE DIFF
Analytical validation standard
Related substances, system suitability
Jan 2026
Philippines NRA
Not on the recognised list
NO ACTION
Container closure standard
Extractables and leachables
Nov 2025
Peru NRA
Recognised, transition to Jun 2027
WATCH
Elemental impurities standard
Permitted daily exposure limits
Aug 2026
Thailand NRA
Under review by the authority
NO ACTION YET
GMP inspection standard
Site certificate scope wording
Jun 2026
Ethiopia NRA
Adopted, effective immediately
TEMPLATE DIFF
SOURCEEach authority's own recognised-standards register, re-read on publication. Recognition is per authority and per jurisdiction — an adoption in one market says nothing about another, and the platform will not infer one from the other.
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.