Brazil’s regulatory framework for drugs is undergoing significant modernization, with updates spanning clinical trials, drug registration, pricing, and post-marketing surveillance.

• Clinical Trials & Drug Development
  Key Regulations:
  • Resolution RDC 945/2024: Governs clinical trials for drugs and biologics
  • Law No. 14,874/2024: Requires ethical review by research ethics committees (CEPs)
  • ICH Guidelines E6(R3): Adopted in 2025 for Good Clinical Practice

• Drug Registration & Marketing Authorization
  Updated Guidelines:
  • Resolution RDC 954/2025: Simplifies registration and renewal for drugs within the same economic group
  • Resolution RDC 912/2024: Sets MA validity periods (3–10 years depending on evidence)
  • Resolution RDC 753/2022: Covers synthetic, generic, and similar drugs
  • Resolution RDC 888/2024: Governs OTC drugs

What MAHs Need to Know in 2025

The Windsor Framework, which came into effect on January 1, 2025, brings significant regulatory transformations to pharmacovigilance (PV) practices throughout the United Kingdom. In this new landscape, Great Britain (GB) adheres to the established UK PV legislation, while Northern Ireland (NI) remains committed to the European Union’s Good Vigilance Practices (GVP) standards for Category 2 products.

This divergence necessitates that Marketing Authorisation Holders (MAHs) navigate two distinct regulatory environments, requiring them to implement and refine their processes to ensure compliance with both sets of regulations. As a result, MAHs must invest in robust systems and training to effectively manage the complexities of dual compliance, thereby safeguarding public health while maintaining the integrity of their operations in both regions.

Key Changes:

• Removes EU licensing processes in relation to Northern Ireland for novel medicines (those that were authorised under the EU Centralised Procedure) – medicines authorisations granted by the EC will no longer be valid in Northern Ireland
• Removes any requirement for EU Falsified Medicines Directive (FMD) packaging, labelling and serialisation barcode for medicines in Northern Ireland
• Requires all medicines placed on the UK market to be labelled ‘UK Only’, indicating they are not for sale in the Republic of Ireland or other EU countries
• Licences will be UK wide; Companies will no longer need to apply for separate licenses for Great Britain and Northern Ireland

If you are looking to navigate the complex regulatory environment in China, particularly concerning the reporting requirements for clinical trials and post-authorization processes, IntuVigilance is here to assist you.

We are excited to announce that IntuVigilance has established a presence in China, offering comprehensive regulatory affairs and drug safety / pharmacovigilance services. Our expertise is designed to help you overcome the challenges associated with compliance and reporting, ensuring that your operations align with local regulations and standards.

We can manage the intricacies of regulatory requirements, providing you with peace of mind in a rapidly evolving landscape.

Colombia’s pharmacovigilance system for medications has historically been guided by Decree 2200 of 2005.

The latest regulation concerning pharmacovigilance in Colombia is Resolution 2024015321 of 2024, which outlines the framework for the National Pharmacovigilance System (SNFV).

This resolution sets forth the requirements for pharmacovigilance officers, introduces a risk-based classification for holders of marketing authorization, and enhances the processes for the reporting and analysis of adverse events on a national scale.

On June 24, 2025, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) officially adopted three key guidelines from the International Council for Harmonisation (ICH)—E2A, E2F, and E3—through its new regulation (ANMAT Disposition 4385/2025).

What this means:

• ICH E2A (Clinical Safety Data Management): Establishes clear definitions and standards for expedited safety reporting.
• ICH E2F (Development Safety Update Report): Standardizes the format and content for safety update reports during clinical development.
• ICH E3 (Clinical Study Report Structure): Defines the structure and content required for comprehensive clinical study reports.

By adopting these internationally recognized guidelines, ANMAT aims to:

✅ Harmonize local regulatory frameworks with high-standard global criteria.

✅ Improve the traceability, transparency, and quality of safety and final clinical reports.

✅ Provide sponsors with clear, standardized tools—ensuring reports are complete, well-organized, and easy to review.

✅ Strengthen the supervision of clinical trials carried out in Argentina.

This initiative underscores Argentina’s role as an official member of the ICH Regulator since June 2024, highlighting the nation’s commitment to aligning its pharmaceutical regulations with global standards.

Why it matters?

Aligning with ICH standards enhances the credibility of clinical research, supports patient safety, and fosters international collaboration in drug development.

National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published an updated version of the Guidelines for the Implementation of Drug Information Leaflets for Consumers (RiMUP), effective from 01 April 2025.

Digital Submission via QUEST3+: Starting April 2025, all RiMUPs for evaluation by the Pharmacovigilance Section (PKKK) must be submitted through the QUEST3+ system, replacing manual submissions

With our Ikyzen system, you will benefit from continuously updated information that reflects changes in regulatory frameworks across various nations.

Mandatory XML Submission
As part of the regulatory updates, it is important to note that the submission of adverse event reports in the XML (E2B) format will become mandatory for all pharmaceutical companies in Mexico. This shift underscores the need for companies to prepare for compliance with the new requirements.

The implementation of the E-reporting Industria system and the transition to mandatory XML (E2B) submissions represent significant advancements in pharmacovigilance practices across LATAM. By understanding these key aspects and preparing accordingly, pharmaceutical companies can navigate the regulatory landscape effectively and contribute to enhanced drug safety in the region.

Our Pharmacovigilance (PV) Team in Africa brings a wealth of expertise in Regulatory Intelligence and Pharmacovigilance processes. With a deep understanding of both post-commercialized products and clinical trial legislation, our team is well-equipped to navigate the intricate regulatory landscapes across various countries in the African region.

The varied regulatory landscapes across Africa present considerable challenges for pharmaceutical companies. Our expertise allows us to navigate these complexities effectively, ensuring adherence to local regulations while maintaining a strong focus on safety in drug monitoring and reporting.

Anyone working in Pharmacovigilance these days knows that some (not all) EU Member States stipulate a requirement for a local QPPV (LQPPV). Some say that the presence of a EU QPPV will suffice. Others mention a ‘Responsible Person’ for PV; Germany needs a ‘Stufenplanbeauftragter’. Regardless of nomenclature, wherever stipulated, broadly speaking this tends to align with the qualifications and responsibilities assigned to the LQPPV.

Other countries in turn, refer to a need for a named safety contact (NSC) i.e. a safety contact who doesn’t carry legal liability for the product however must be the main safety contact in the country for the regulatory authority. In some countries, a NSC performs most of the safety tasks designated to the LQPPV, however is not legally liable for the safety of a given product in a given country.

At first glance, 53 global countries (and counting) stipulate either a NSC or a LQPPV requirement. Interestingly, legislated
requirements for a LQPPV also exist in countries outside of the EU member states. However their responsibilities and qualifications seem to vary enormously. Whilst some countries stipulate a physician, others want a pharmacist. Whilst some have a list of responsibilities for their LQPPV or NSC, others tend to dilute their requirements to ‘supporting the EU QPPV’.

Regardless of how the roles are described within specific legislation, notwithstanding the fact that NSCs appear to carry far less legal responsibility than LQPPVs, and aside from the fact that these days ROW countries are also stipulating the need for these persons to be resident in the country, it does appear prudent to appoint a NSC in any country that doesn’t stipulate a LQPPV regardless of country legislation. But is it really?

It goes without saying (so I will say it) that it is challenging for the EU QPPV to maintain oversight of their local QPPVs across all territories EU and/or otherwise. Should we now extend that oversight to include NSCs? After all, a NSC within a given country is the point person for the authority regarding a given product in that territory. Should NSCs have a more defined role such as that of the LQPPV? Is there a need to align global PV requirements around NSCs? If a country doesn’t stipulate a LQPPV or NSC does it mean that there is no need for oversight in that country? Should companies appoint an NSC in affiliate territories regardless of a requirement in the country? Does it matter if a NSC within one of our affiliates is a Sales or Logistics person? Where does the EU QPPVs oversight stop regarding local responsibilities of an NSC?

Some food for thought.

The ‘Oscars’ of the pharma industry were held on the 22nd of May in Kensington, London and Intuvigilance picked up the coveted award for the Best Compliance and Quality Assurance company 2018.

The International Award of Excellence Pharma Awards are awarded to International Pharmaceutical and Biotechnology Companies, Scientists, Auditors, C-Level Executives, Pharma Leaders and Solution Providers with proven State of Excellence and Recognising Individuals / Organisations for their Outstanding Achievements & Dedication towards Pharmaceutical Research, Development, Safety and Monitoring.

The IAE is the only Award which brings together Top International Professionals and Pharma Leaders under one roof from around the globe to recognise excellence and the IntuVigilance team were on hand to collect the prestigious award on the night.

The votes and generous support of our esteemed colleagues and amazing clients helped to catapult us into first place. To be nominated for an award in the Pharmacovigilance Industry is precious enough for a humble group like IntuVigilance, but to be selected as winners within a category that forms the pillars on which Pharmacovigilance resides, is high praise indeed. The Team are humbled to receive this award, and we wish to thank all our clients, friends and colleagues for your kind words and support.

IntuVigilance boasts a plethora of subject matter experts to suit your Drug Safety and PV needs. Our team is dedicated to providing innovative and diligent solutions that are synonymous with the ethos and values of IntuVigilance.