Pharma – Asia, S America, MENA, ROW Regulatory News – Sep 2026

Australia

TGA Mandates New eCTD AU Module 1 Version 3.2 Format for Prescription Medicine Submissions.

On 4 September, 2026, theTherapeutic Goods Administration (TGA) updated its official guidance to mandate the eCTD AU Module 1 Version 3.2 format for all prescription medicine submissions, making the previous Version 3.1 outdated. This updated framework introduces revised validation criteria and improved section headings to streamline application reviews, ensuring sponsors comply with the new technical rules to prevent automatic rejections at the submission gateway.

Brazil

Mexico Launches 45-Day Fast-Track Approval for New Pharma Products via Brazil’s Anvisa Recognition

On September 3, 2026, Mexico’s regulatory authority, the Federal Commission for Protection against Sanitary Risks (Cofepris), launched a simplified fast-track procedure that reduces drug registration timelines from years down to a maximum of 45 business days. This new rule applies strictly to pharmaceutical products containing new molecules that have already received a valid authorization from Anvisa (the Brazilian Health Regulatory Agency).

Canada

Health Canada Launches Access Consortium Data Pilot to Speed Innovator Drug Review

On September 14, 2026, Health Canada launched a pilot project allowing the agency to request new safety and efficacy data from the applicant during joint reviews under the New Active Substances Work-Sharing Initiative (NASWSI) for innovator submissions. Designed to reduce red tape and align with international Access Consortium partners, the policy enables Health Canada to issue these data requests to the applicant during the consolidated list of questions (LOQ) phase. This proactive mechanism helps the applicant avoid application rejections or formal delays like a Notice of Deficiency (NOD) or a Notice of Non-compliance (NON).

Health Canada Modernizes Drug Clinical Trial Framework Ahead of 2028 Regulations

On September 14, 2026, Health Canada issued an interim policy notice modernizing the clinical trial framework for drug products to align with international standards ahead of new regulations expected in spring 2028. To streamline multi-site drug trials, an applicant using a coordinated Research Ethics Board (REB) only needs to provide the board’s contact information once, while the applicant remains responsible for keeping complete approval records for clinical trial inspections. The policy also expands “qualified investigator” eligibility to competent non-physicians, provided the applicant ensures a licensed physician oversees all medical decisions and participant care. Lastly, it transitions from “written” to “documented” informed consent, allowing an applicant to officially use remote or electronic platforms and digital signatures to confirm participant consent in pharmaceutical trials.

Egypt

Egypt EDA Launches Public Consultation on Draft eCTD Submission Guidance

On September 2, 2026, the Egyptian Drug Authority (EDA)officially launched a public consultation for its newly drafted regulatory guidance, Technical Guidance for eCTD Submissions in Egypt. Jointly spearheaded by the Central Administration for Pharmaceutical Products and the Central Administration for Biological and Innovative Products and Clinical Trials, this initiative marks a major milestone in Egypt’s digital transformation of drug regulation. The EDA invites the applicant and all industry stakeholders to review the draft and submit their regulatory comments, insights, and suggestions via the official Stakeholder Feedback Form. The public comment window is open through October 14, 2026. To complete the submission, the applicantmust email the completed form to the respective department for human pharmaceutical products.

Germany

BfArM Updates Slot Booking Rules for DCP and National Applications

Effective September 8, 2026, the BfArM requires mandatory slot bookings for all Decentralised Procedures (DCP) and purely national applications. Applicants must submit a completed request form via email and confirm their assigned submission month within one week, or the slot will be released. To prevent check-in delays, submissions should be sent during weeks 2 and 3of the chosen month. The rules allow a one-time delay of up to one month, as long as the applicant gives at least two months’ notice; otherwise, missing the slot means the applicant will lose it entirely. Slots cannot be transferred, meaning any changes to the applicant, product swaps, or major changes to the active substancerequire a brand-new application. Additionally, Article 10a (well-established use) applications are only allowed if no reference product exists in the EU,and Active Substance Master Files (ASMF) will be rejected if a Certificate of Suitability (CEP) is available from any manufacturer in the EU.

Switzerland

Swissmedic Announces Launch of ElViS 2.0: Transitioning to E2B(R3) ADR Reporting Format

On September 21, 2026, Swissmedic announced the launch of ElViS 2.0, an upgraded Electronic Vigilance System going live on 21 December 2026 to support the internationalE2B(R3) formatforAdverse Drug Reaction (ADR) reporting. For healthcare professionals, the platform introduces minor layout updates, a new direct messaging feature, and login via AGOV or HIN. For the applicant (marketing authorisation holder), the system offers critical compliance pathways, allowing manual entries or E2B file uploads. Existing E2B R2.1 files uploaded by the applicantcan be manually amended to meet the R3 regulatory compliance standard before transmission, while downstream feedback from Swissmedic will be issued in R3 format and downloadable as E2B(R3), E2B R2.1, or PDF. To ensure operational readiness, Swissmedic will publish specification documents and host an online training session for the applicant in early December 2026.

2. Swissmedic to Release New Portal Update for Complementary Medicines (Chapter 7 KPAV)

On September 23, 2026, the Swissmedic portal for marketing authorization holders will publish the technical data for complementary medicines in the notification procedure (Chapter 7 KPAV). This will give the applicant access to the technical data for company-based dossiers, master dossiers, and individual medicinal products (individual notifications) belonging to their organization. To use the Swissmedic portal and view the data, the applicant needs the appropriate authorization and should contact the person responsible for administration within their company.