https://aupameo.org/#whatsnew Additions and updates to the AUPAM Experts' Office platform — tools, datasets, and the monthly regulatory report for the 22 Arab pharmaceutical markets. en Mon, 31 Aug 2026 09:00:00 +0000 https://aupameo.org/datasets/ aupam-2026-08-31-record-pages Mon, 31 Aug 2026 12:00:00 +0000 Every record in the open datasets now has its own bilingual, citable page — 375 reference comparators, 363 substances, 26 solved problems — findable by the specific search a professional actually types. The calculators gained landing pages under /tools, and the Morning Brief can now be embedded on any site with one line of HTML, fed live by the office's monitors. https://aupameo.org/#briefing aupam-2026-08-31-morning-brief Mon, 31 Aug 2026 10:00:00 +0000 The homepage now opens on a three-column brief: Arab regulators, international agencies, and the newest GMP enforcement — every line a dated row from the office's own monitors (the Regulatory Index updates daily, the Enforcement Watch twice a week, the Change Radar weekly), with its source a click away. The freshness stamp is the newest entry date actually present; nothing is typed by hand. https://aupameo.org/#academia aupam-2026-08-31-social-academia Mon, 31 Aug 2026 09:00:00 +0000 Every citable section now carries a share row — LinkedIn, X, Facebook, WhatsApp, Telegram, email and copy-link — plain links that load nothing until clicked. Every dataset and the monthly report copy as BibTeX or RIS alongside the plain citation. A new Research & Academia section gathers the crawlable dataset pages, the citation formats, the teaching material and the corrections channel; the crawlable pages gained social cards and citation blocks of their own. In the Expert Relay, a task now goes to one expert or the whole team with files attached, each expert ticks their own done, and every task keeps a copy on the office server so it follows you across devices. https://aupameo.org/#gmp aupam-2026-08-17-gmp-interview Mon, 17 Aug 2026 09:00:00 +0000 All 164 interview questions in the GMP Live-Inspection Dashboard now carry an expected answer: what a compliant site says and shows, three or four things the inspector must hear or see with one marked as the must-have, what a weak answer sounds like, what to ask to see, and one line of coaching for a first inspection. The verdict is computed from the ticks rather than typed, so two inspectors with the same ticks reach the same answer; overrides require a reason and are journalled. The interview record folds into the sealed record, prints as its own document and exports as CSV. Release v25. https://aupameo.org/CCS_Contamination_Control_Dashboard_v1.html#lifecycle aupam-2026-07-29-ccs-lifecycle Wed, 29 Jul 2026 14:00:00 +0000 Every panel in the tool described a snapshot; none knew what year it was. The new Review and Change module answers clause 2.6, which asks for a change to be assessed before implementation and again after — the second assessment being the half sites skip, so it is counted on its own. Record a review and today’s scores are fixed as a baseline; at the next review every score that moved is listed with its old and new value. On the interval the tool invents nothing: Annex 1 sets none, so the cadence is the site’s to justify. The new half is the cross-check. A barrier score is judgement, a media fill result is not, so the tool reads the contaminated units, control-chart signals, requalification dates, disinfectant efficacy figure and gowning compliance rate the same person entered elsewhere, and names every place a score claims more than the records support. Six checks, each narrow enough to point at one recorded fact and one barrier. https://aupameo.org/#biosimilar?tab=peptide aupam-2026-07-29-peptide-frontier Wed, 29 Jul 2026 12:00:00 +0000 Added the day after FDA published seventeen revised draft product-specific guidances for peptide products and withdrew the 2021 guidance governing synthetic peptide generics. The bench settles which side of the border a molecule sits on — at 40 amino acids or fewer it is a drug and a copy is a generic, above that it is a protein and a copy is a biosimilar — then sets the six changes of 28 July against the December 2025 versions they replace. Four of the six make the generic route easier: the abbreviated pathway is now open to recombinantly and semi-synthetically produced peptides, the impurity identification threshold moved from 0.10% to 0.5%, the new-impurity ceiling doubled to 1.0%, and innate immune testing became optional. One got harder: three of your batches at release and end of shelf life against three reference batches aged near expiry, which is a calendar problem measured in years. https://aupameo.org/CCS_Dashboard_Tour.html aupam-2026-07-28-ccs-tour Tue, 28 Jul 2026 12:00:00 +0000 A four-minute walkthrough narrated in English, with Arabic captions. It opens on the question Annex 1 clause 2.4 actually asks, scores a single contamination route on screen, collapses three procedures resting on one training system into the single layer they really are, and closes on the constants the industry repeats wrongly. Each scene is timed to the length of its own recording rather than to an estimate, so the picture turns with the voice. https://aupameo.org/#ccs aupam-2026-07-28-ccs-command Tue, 28 Jul 2026 09:00:00 +0000 A second flagship dashboard beside the GMP one, answering Annex 1 clause 2.4 rather than restating it: fourteen routes by which contamination could reach the product, the barriers standing on each, and barriers grouped by common cause so three procedures resting on the same training system count as one layer instead of three. Routes with no effective detective control are named unprotected however deep they look. The first build multiplied breach probabilities and rated a strategy whose six barriers were every one of them weak at 98.9 per cent protected, so the percentage was removed entirely and the tool now counts effective layers. Verification against the primary EC and PIC/S text also overturned six constants the industry publishes, including the grade A viable limit (No growth, not less than 1 CFU) and the tiered media-fill rule (FDA 2004, not Annex 1, which allows no contaminated unit at any run size). The Annex 1 tables, the sources panel and one full route are open without a passcode. https://aupameo.org/#gmp aupam-2026-07-27-gmp-record-lock Mon, 27 Jul 2026 17:00:00 +0000 The last open Part 11 requirement was that anyone who could open the file could read the inspection. An optional record lock now closes it: the plaintext is removed from the device and only an encrypted envelope remains. It is off by default, it is not AES, and the tool states both in the same panel — forget the passphrase and the record is unrecoverable, which is the property that makes it worth anything. Separately, EU GMP Part I is now registered chapter by chapter and points resting entirely on verified sources rose from 146 to 216 of 265. https://aupameo.org/#gmp aupam-2026-07-27-gmp-esignature Mon, 27 Jul 2026 13:00:00 +0000 A signer enrols with a unique identifier that is never reused and a private passphrase that is never stored (only a salted digest of it, derived over 20,000 rounds). Both are demanded at every signing, and the signature is bound to the record content and the credential together, so it cannot be moved onto another record. Three attacks were tested and the results published. Separately, ten more guideline families were re-checked against their primary documents: no family in the register is now unverified, and 146 of the 265 checklist points rest entirely on sources verified this month, up from 51. https://aupameo.org/#gmp aupam-2026-07-27-gmp-qualification Mon, 27 Jul 2026 09:00:00 +0000 The GMP Live-Inspection Dashboard runs its own installation and operational qualification (23 documented test cases, printed as a signable protocol), states its Part 11 and Annex 11 position requirement by requirement including the two it cannot meet, hands findings to a deviation or CAPA system as a 23-field import, saves a durable archive, asks for a reason when a severity changes, and records the meaning of each signature. https://aupameo.org/GMP_Inspection_Dashboard_v12.html aupam-2026-07-26-gmp-tool Sun, 26 Jul 2026 18:00:00 +0000 Rebuilt the GMP Inspection Dashboard as v15. The Assurance Centre adds a tamper-evident sealed record signed by both parties and verifiable offline, citation integrity, a PIC/S PI 040 classification assistant, CAPA effectiveness checks and a severity benchmark against MHRA's published 2019 dataset. The Field Kit writes the same inspection in EU/PIC S, WHO-style or Arabic-first layouts, merges two inspectors' packs with side-by-side conflict resolution, and models a transparent site risk trajectory. https://aupameo.org/#vamfdc aupam-2026-07-26-newsletter Sun, 26 Jul 2026 12:00:00 +0000 Published Regulatory Brief Part II — Approved in Washington, Prohibited in New Delhi — as tab 6 of the Value-Added & Combination Studio. https://aupameo.org/#stateof aupam-2026-07-21-report Tue, 21 Jul 2026 08:00:00 +0000 Launched The Arab Pharmaceutical Regulatory Report — a dated, citable monthly snapshot of the office's datasets. https://aupameo.org/#trust aupam-2026-07-21-trust Tue, 21 Jul 2026 08:00:00 +0000 Opened the Trust Centre: how we verify, where your data goes, our sources, and the honesty pledge. https://aupameo.org/#databank aupam-2026-07-21-data-bank Tue, 21 Jul 2026 08:00:00 +0000 Expanded the API & Excipient Data Bank and added sort, CSV export, and shareable filtered links. https://aupameo.org/#biosimilar?tab=precedent aupam-2026-07-21-biosimilar Tue, 21 Jul 2026 08:00:00 +0000 Added the analytical-similarity Precedent Library and a copy-link permalink to every studio view. https://aupameo.org/#biosimilar?tab=atlas aupam-2026-07-20-biosimilar Mon, 20 Jul 2026 08:00:00 +0000 Published the Arab Reliance Atlas — the biosimilar route for each of the 22 Arab markets. https://aupameo.org/#biosimilar?tab=ledger aupam-2026-07-19-biosimilar Sun, 19 Jul 2026 08:00:00 +0000 Opened the Global Biosimilar Approvals Ledger (273 approvals) with monthly automatic refresh. https://aupameo.org/#boardroom aupam-2026-07-18-boardroom Sat, 18 Jul 2026 08:00:00 +0000 Added the Decision Engine and the CEO Academy to the Boardroom. https://aupameo.org/#boardroom aupam-2026-07-16-boardroom Thu, 16 Jul 2026 08:00:00 +0000 Shipped the First-Filer Window Radar, the Margin-at-Risk Console and the Tender & Localization Suite. https://aupameo.org/#databank aupam-2026-07-13-data-bank Mon, 13 Jul 2026 08:00:00 +0000 Compiled the API & Excipient Data Bank as a browsable sourcing catalog for the Supply Studio. https://aupameo.org/#enforcement aupam-2026-07-09-intelligence Thu, 09 Jul 2026 08:00:00 +0000 Turned on the Enforcement Watch — a self-updating feed of published GMP 483s and warning letters.