Pharma – Canada, S America, MENA and Asia Regulatory News – Oct 2026

Argentina

ANMAT Mandates QR and Data Matrix Codes on Medicine Packaging for Real-Time Digital Leaflets

On October 19, 2026, the Argentine National Administration of Medicines, Food and Medical Technology (ANMAT) highlighted the mandatory implementation of two-dimensional codes (QR and Data Matrix) on pharmaceutical packaging by applicants and Marketing Authorization Holders (MAHs) under Provision No. 2891/26, granting healthcare professionals and patients instant digital access to real-time, agency-approved safety information and patient information leaflets provided by companies featuring plain language, adjustable fonts, and audio support, while temporarily permitting traditional paper inserts to legally coexist alongside the new digital system implemented by sponsors.

ANMAT Approves Record 291 Clinical Studies in 2026, Accelerating Argentina’s Rise as a Pharma Hub

On October 13, 2026, Argentina announced that ANMAT approved a record 291 clinical studies from January to September—a 36% increase over last year. Supported by over 700 health centers and international standards like ICH guidelines, this growth helps sponsors, applicants, and MAHs streamline drug development and strengthens Argentina as a top destination for clinical research.

Canada

Q3 2026 Update: Health Canada Clears 16 New Prescription Drugs and Speeds Up Approvals

On October 15, 2026, regulatory authority Health Canada announced the approval of 16 new prescription drugs for July to September 2026. To improve patient access and manage complex reviews, the agency is advancing clinical trial modernization (featuring a new trial information portal and pediatric study pilots), reducing pediatric review timelines by 40% (from 300 to 180 days), and launching an international work-sharing group called the Access Network to speed up approvals while maintaining strict safety, efficacy, and quality standards.

China

China Authorizes First Seaport Border Entry to Streamline Raw Drug Material Imports                        

On October 22, 2026, the China National Medical Products Administration (NMPA) and the General Administration of Customs issued Announcements No. 93 and No. 94, designating Qinzhou Port in Guangxi as China’s first seaport border entry for importing raw traditional Chinese medicinal materials, alongside Shuangshuihe and Houqiao land ports in Yunnan. This regulatory update allows local market regulators to handle direct on-site customs clearance, drug registration checks, and regulatory safety inspections, streamlining supply chains and reducing logistics costs for pharmaceutical importers, manufacturing companies, and Marketing Authorization Holders (MAHs) operating across South and Southwest China.

Egypt

EDA Updates Pharmaceutical Variation Guidelines (Version 2/2026): New CTD Timelines and Dossier Rules

On 15th October 2026, the Egyptian Drug Authority (EDA) outlined that human pharmaceutical product variations are managed using a standardized Common Technical Document (CTD) format aligned with Egypt’s Sixth Edition Guidelines. Under Version 2/2026 of the “Notice to Applicant” guideline, the applicant must adhere to strict processing timelines: 15 working days for submissions without evaluation, 45 working days for submissions processed via evaluation, and 60 working days for post-marketing approvals. Additionally, the applicant must compile a comprehensive dossier specifying active substance manufacturers, strict excipient limits, and precise product packaging parameters for both local and imported pharmaceutical products.

EDA Seeks Industry Comments on Draft CTD Submission Guidance (Version 6)

On 15th October 2026, the Egyptian Drug Authority (EDA) launched a public consultation on the draft Notice to applicants titled “Submission Guidance for The Common Technical Document for Human Pharmaceutical Products (Version 6)”. Open from October 15 to October 29, 2026, the initiative aims to develop and unify pharmaceutical registration file submission mechanisms under the Common Technical Document (CTD) system. Applicants are invited to share their feedback using the designated “Stakeholder Feedback Form” via email at

Malaysia

National Pharmaceutical Regulatory Agency (NPRA) Announces 2026 Year-End Payment Closures for Pharmaceutical Products

On 13 October 2026, the National Pharmaceutical Regulatory Agency (NPRA) notified pharmaceutical companies and applicants regarding the 2026 year-end payment closure schedule for pharmaceutical products. Online transactions via the QUEST3+ system close on 18 December 2026, while over-the-counter payments at the NPRA Finance Section Revenue Counter operate until 30 December 2026. To prevent processing delays, applicants and pharmaceutical companies are advised to complete all mandatory regulatory payments such as new applications, renewals, and product notifications ahead of time, with all normal payment operations resuming on 4 January 2027.

National Pharmaceutical Regulatory Agency (NPRA) Switches to PIC/S (PE 009-18) Standard for GMP Inspections

On 7th October 2026, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) officially adopted the PIC/S Guide to Good Manufacturing Practice (PE 009-18) as its new standard for GMP inspections, effective 24 September 2026. This updated framework incorporates the revised Annex 19, which establishes clearer requirements for (Reference and Retention Samples) under Section 9, specifically impacting pharmaceutical companies, manufacturing applicants, and marketing authorization holders dealing with parallel imported, distributed, or traded products. Regulated companies and applicants must review these updates and revise their internal Quality Management Systems (QMS) and standard operating procedures to ensure ongoing compliance.

Philippines

Philippine FDA Announces VigiFlow eReporting User Manual Launch and Mandatory Training for Market Authorization Holders

On October 26, 2026, the Philippine Food and Drug Administration (FDA) announced the release of the VigiFlow eReporting User Manual for Industry, alongside an in-person training program on November 4, 2026. To ensure regulatory compliance, participation is strictly limited to one representative per Market Authorization Holder (MAH) with an active account, offering free registration on a first-come, first-served basis that must be completed online by October 29, 2026.

Philippine FDA Launches “FDA RESET” Initiative to Streamline Regulatory Processes and Enhance Transparency for MAHs and Sponsors

On October 19, 2026, the Philippine Food and Drug Administration (FDA) launched its “FDA RESET” program under Director General Margarita M. Gutierrez to transform the agency into a more efficient, accountable, and trusted health regulator. For applicants, companies, marketing authorization holders (MAHs), and sponsors, this initiative relies on Regulatory Efficiency, Systems Thinking, Empowerment, and Digital Transformation to eliminate administrative bottlenecks, enforce strict integrity standards, and introduce digital tracking, ensuring faster processing and timely access to safe health products.

Saudi Arabia

SFDA and Saudi NIH Launch Five Strategic Initiatives to Transform Clinical Trials and Accelerate Innovative Drug Approvals

On 7th October 2026, the SFDA and Saudi NIH launched five strategic initiatives in Riyadh to transform the clinical trials ecosystem and accelerate innovative medicine approvals under Vision 2030. This collaborative framework introduces the Clinical Trials Agreement Reference Model, Clinical Trial Units Guideline, Hospitals and Research Centers Profile, Clinical Trials Reliance Pathway, and RAID Pathway to strengthen research infrastructure and streamline regulatory processes.

Singapore

Singapore’s HSA Fast-Tracks Drug Approvals with New Global and Local Reforms

On 12 October 2026, Singapore’s Health Sciences Authority (HSA) announced major regulatory updates to accelerate market authorization for novel therapeutic products. HSA established a Regulatory Innovation Corridor with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to streamline regulatory pathways for Artificial Intelligence (AI) and breakthrough therapies. Furthermore, starting November 2026, HSA and the Agency for Care Effectiveness (ACE) will conduct concurrent regulatory evaluation and health technology assessment (HTA) to reduce time-to-decision for applicants and sponsors. Finally, under legislation passed in September 2026, HSA is transitioning into a consolidated regulatory authority, assuming Ministry of Health regulatory functions on 1 November 2026 to ensure a more efficient and predictable regulatory framework.

Thailand

Thai FDA Highlights “FDA ON Health UP” Strategy in Collaborative Meeting with AMCHAM

On 10 October 2026, the Thai FDA (led by Secretary-General Ms. Supattra Boonserm) and AMCHAM (led by Vice President Ms. Wiyada Srinaganand) met to align local drug standards with international practices. AMCHAM presented its “Forward Five 2026” recommendations and commended the Thai FDA for digital submission systems and priority review pathways for medicines. In response, the Thai FDA highlighted its “FDA ON Health UP” strategy, aiming to simplify the marketing authorization process and assist applicants, sponsors, and pharmaceutical companies in bringing innovative treatments to market safely and efficiently.

Thai FDA Sets Urgent Deadlines for 2026 Drug Registration Renewals

On October 5, 2026, the Thai Food and Drug Administration (Thai FDA) announced that 1,169 out of 3,503 transitional drug applications still lack mandatory renewal files. Pharmaceutical applicants and license holders must submit digital renewals via the Skynet system by October 12, 2026, to secure a late-fee waiver. Submissions filed during the grace period up to November 13, 2026, will face daily penalties of up to 500 Baht. The Thai FDA applies a 30-working-day initial check and a 120-working-day review, with current drug approvals remaining active during evaluation once initial fees are paid.

UAE

Emirates Drug Establishment and SEHA Partner to Strengthen Medical Product Regulation and Scientific Assessment

October 22, 2026, the Emirates Drug Establishment (EDE) advanced national pharmaceutical oversight and supply chain resilience during the Abu Dhabi Future Health Summit 2026. EDE partnered with the Abu Dhabi Health Services Company (SEHA) through a strategic memorandum to enhance the scientific review, product evaluation, and regulatory assessment of pharmaceutical products by integrating clinical experts into technical advisory committees. Additionally, EDE supported the Mubadala Bio-Lilly agreement to localize final-stage pharmaceutical manufacturing and distribution logistics, bolstering domestic supply chain security and regulatory compliance in the UAE.