POST-MARKET · DEFICIENCY & HAQSYNTHETIC DATARA LEAD · DRUG
Deficiency & Health Authority Queries
What the authority asked after submission, the version that answers it, the statutory clock, and the patterns that keep repeating.
POST-MARKET
Everything here starts with a submission
A deficiency is what an authority asks for after a dossier has been filed — a different object from a pre-market gap, on a different clock, owned by a different person. Each round is answered from the document version that resolves it, signed by RA, and pinned to the round. The pattern then feeds the next audit so the same question is pre-empted rather than re-answered.
Authority Query Rounds
Queries are mostly technical. Each revision is tracked with the reason, so the consolidated approved dossier can be reproduced years later.
Round 2 · Vietnam NRA
11 D WAITINGProvide 20 percent HPLC chromatograms for specific related substances.
Draft assembled from Module 3.2.P.5 v3 — awaiting supplier countersign.
Round 1 · Peru NRA
CLOSED 6 DClarify the excipient origin declaration against the national checklist.
Answered; the answering document version is pinned to the round.
Round 1 · Philippines NRA
3 D WAITINGSubmit the local agent letter of access.
Requested from the partner; template pre-filled.
Supplier Loop
Query received
Routed to manufacturing site
Document returned
Version supersedes, response filed
Technical answers come from the manufacturing site, not from Mega — the loop closes when the supplier returns the document.
Deficiency Patterns
Past questions indexed by market and dossier section, so the same deficiency is pre-empted on the next filing.
3.2.P.56x
Missing chromatograms
Vietnam, Philippines, Peru, Kenya
3.2.P.84x
Stability zone mismatch
Vietnam, Indonesia, Peru
MODULE 13x
Legalised document missing
Ethiopia, Nigeria
3.2.S2x
DMF absent for one API supplier
Vietnam, Thailand
Drafted Response · Vietnam NRA round 2, item 4
Drafted from the exact version that answers the question, with the citation pinned. RA edits and signs; the platform does not send.
AUTHORITY ASKED
Provide chromatograms supporting the related-substances method for the three commercial batches referenced in section P.5.3, including system suitability data and the reference standard certificate applied at the time of testing.
DRAFT RESPONSE
The chromatograms for batches SLX-2401, SLX-2402 and SLX-2404 are provided in the attached annexe, together with system suitability results for each analytical run. The reference standard applied was lot RS-0119, whose certificate is included; the method is unchanged from the version submitted in the original dossier. No revision to section P.5.3 is required as a result of this response.
P.5.3Validation of analytical procedures — related substancesv3
P.5.4Batch analyses — SLX-2401 / 2402 / 2404v2
P.6Reference standard certificate — lot RS-0119v1
HUMAN GATEAwaiting RA sign-off from Nita Deshpande. Nothing is transmitted from the platform.
Query Clock By Market
Statutory response windows, and how much of each one is already spent. The clock starts on receipt, not on assignment.
Vietnam NRA21 days left
Round 2, item 4 — chromatogramsWINDOW 60 DAYS
Philippines NRA9 days left
Round 1, items 2 and 7 — raw batch dataWINDOW 30 DAYS
Peru NRA4 days left
Checklist reissue — resubmit Part IWINDOW 30 DAYS
Ethiopia NRA34 days left
Round 1, item 1 — GMP certificate scopeWINDOW 45 DAYS
Myanmar NRA17 days left
Round 3, item 2 — shelf-life justificationWINDOW 35 DAYS
Uzbekistan NRA2 days left
Round 1, item 5 — certified translationWINDOW 30 DAYS
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.