Information and Privacy Commission NSW’s Post

IPC has issued a notification to it's stakeholders regarding implementation of General Chapter on Elemental Impurities which will become effective in IP 2026. Further notifications in this regard will be published on IPC's website, www.ipc.gov.in Stakeholders are required to make a note of it and initiate the needful for implementation of this General chapter in accordance with principles of ICH Q3D(R2). #CompendialCompliance

Carbon Border Adjustment Mechanism, a very informative document.

::: 𝗘𝗨 𝗖𝗕𝗔𝗠 - 𝗦𝗲𝗹𝗳 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝘁𝗼𝗼𝗹 🔊 New tool to get a quick overview on the CBAM reporting requirements by CN Code. If all information is entered correctly, the green cells will show the outcome of the CBAM Self Assessment and the reporting requirements for the indicated good. More ℹ️⬇️ #EU #EUCBAM #CBAM #Trade #EUTrade #Furthertogether

Are you looking to cancel your SIP but unsure about SEBI's rules and regulations? In this video, we break down the key guidelines you need to know before stopping your SIP Watch Now - https://lnkd.in/gCHYVy6d

The SEBI has issued a Master Circular dated May 07, 2024 related to Registrars to an Issue and Share Transfer Agents in order to enable the users to have access to the applicable circulars at one place. This Master Circular consolidates various directives previously issued to RTAs by SEBI. It supersedes the previous Master Circular for RTAs dated May 17, 2023, and subsequent circulars on the subject. The new Master Circular rescinds previous directives concerning RTAs. However, actions taken under the rescinded circulars prior to this Master Circular remain valid and are considered as having been done under the corresponding provisions of the new circular. Any pending applications with SEBI under the rescinded circulars are now considered under the provisions of the new Master Circular.

Potential pathfinder for a better #IDV #IDPV infrastructure. It’s the kind of large scale public use case where you cannot rely on traditional foundational ID methods that will tease out workable solutions

Great Initiative@NCCPVPI for the guidance document for MAH v2.0 Some Key takeaways: 1. Non Serious case submission to CDSCO Within 90 Calendar days via Email in E2B-R3-XML format 2. Serious case submission to CDSCO within 15 Calendar days via Email in E2B-R3-XML format 3. PSUR Submission in SUGAM Portal (CDSCO website) 4. No requirement to submit foreign Post-marketing ICSRs

今週は、以下４件の記事を更新いたしました。海外事業者向けの日本の再生医療等製品関連の規制についても解説しています（英語記事）。FDAより公開された最新のForm483についても紹介しています。 This week, we have updated four articles, including a detailed explanation of Japan’s regulatory framework for regenerative medical products aimed at overseas businesses. We also introduce the latest FDA Form 483 that has recently been made public. 1. Release of the revised version of the Q&A for ICH Q8/Q9/Q10 – Tets Takarada 【日本語】 2024年10月30日にICH Q8/Q9/Q10のQ&AがR5へ改訂されました。主な変更点は、RTRT（リアルタイム放出試験）の適用条件追加と、Q9(R1)に基づくリスク評価視点の追記です。 【English】 On October 30, 2024, the Q&A for ICH Q8/Q9/Q10 was revised to R5, mainly clarifying conditions for Real-Time Release Testing and incorporating Q9(R1)-based risk assessment. 詳細はこちら https://lnkd.in/g_qqCnhv 2. Regulations related to GMP in Japan – Tets Takarada 【日本語】 日本向け医薬品は医薬品医療機器等法に準拠し、品質・有効性・安全性を審査後に承認され、製造施設はJ-GMPに適合が必要です。補足通知や事例集、PIC/S GMPを参考にシステム構築を行います。 【English】 Pharmaceuticals in Japan must comply with the PMD Act, receive approval after quality, efficacy, and safety reviews, and ensure their manufacturing site meets J-GMP standards. Supplementary notifications, case studies, and PIC/S GMP guidelines are used for system development. 詳細はこちら https://lnkd.in/gDQyJ-tv 3. Current Regulatory Status of Regenerative Medicine and GMP/GCTP in Japan 【日本語】 再生医療製品として流通する場合は医薬品医療機器等法とGCTP省令が適用され、医療行為として提供される場合は再生医療等の安全性の確保等に関する法律に従います。医療機関には施設登録時に建物、更新時に運用面も査察される場合があります。 【English】 Regenerative medicine products are subject to the PMD Act and GCTP Ordinance if marketed as products, or the Act on Ensuring the Safety of Regenerative Medicine if provided as medical services. Facility registration initially focuses on the building, while subsequent renewals may involve operational inspections. 詳細はこちら https://lnkd.in/gSzkByZy 4. 【FDA Form483】根本原因の調査～ヒューマンエラーでは片付けられない～ 【日本語】 2024年9～10月にQuVa Pharma社の製造施設査察でFDA Form 483が公開。無菌製剤における微生物汚染原因調査やクレーム対応調査などが「ヒューマンエラーのみ」とされ、不十分と指摘されています。 【English】 Between September and October 2024, FDA inspections at QuVa Pharma’s facility led to a Form 483 highlighting insufficient root cause investigations, including attributing microbial contamination solely to “human error” and inadequate complaint handling. 詳細はこちら https://lnkd.in/gqbfBEPr ご興味のある方は、ぜひ各リンクから詳細をご確認ください。

We've published a new video demo showing how to achieve EUDR compliance with Eskuad's field data solutions. It applies to any other standard (SFI/FSC, etc.). It's a quick and easy DIY guide to creating forms, collecting data (even offline! Yes, seamlessly, no additional clicks or learning), and generating reports. Check it out here: https://lnkd.in/eW2e5wYR

For Certification Authorities that issue public trust S/MIME certificates, here's a friendly reminder that the following requirements from the S/MIME Baseline Requirements kick in on September 15, 2024: 📌 SHALL use compliant ICA, transition end for Extant ICAs (from version 1.0.1, ballot SMC03) 📌 SHOULD adopt CAA for S/MIME, CPS update required (from version 1.0.3, ballot SMC05)  📌 SHALL check Active status of Legal Entity Applicants (from version 1.0.4, ballot SMC06)