Freyr Solutions

  INVIMA has launched an exceptional plan to unblock thousands of regulatory procedures in Colombia. If your company is in the process of obtaining a marketing authorization, this is essential information. While it doesn’t introduce immediate regulatory changes or set new official timelines, the plan signals the beginning of an operational transition: a phase aimed at enhancing INVIMA’s responsiveness, optimizing internal workflows, and reducing backlogs. For pharmaceutical companies —both local and international— this represents a  tactical window to move forward strategically, gain competitiveness, and accelerate market entry . WHAT DOES THIS PLAN MEAN FOR PHARMACEUTICAL COMPANIES? The  Contingency Plan  does not replace existing regulations or redefine processing timelines. However, Resolution 2025010547 does introduce concrete measures such as: Redistribution of technical staff Extended working hours Prioritization of backlogged submissions These actions could tr...

  INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the entity responsible for the surveillance activities of medicines in Colombia, and   new regulation has recently come into effect, impacting all Marketing Authorization Holders (MAHs)   . Here’s what every MAH should know Pharmacovigilance System Master File (PSMF): MAH must establish a PSMF describing the pharmacovigilance activities, responsibilities, and verification activities performed for the marketed products; this file must be available in Spanish. In addition to the documentation framework, INVIMA has emphasized the importance of having a qualified local representative, as follows. Appointing a Local Person Responsible for Pharmacovigilance (LPPV): MAH must nominate a LPPV before INVIMA; this person must be a physician or pharmacist, reside in the country, and be available permanently and continuously. This person will be the point of contact for safety matters related to the m...

  As Japan continues to evolve its regulatory framework, pharmaceutical companies need to stay ahead of changes that could significantly impact their market access. The   electronic Common Technical Document (eCTD) , mandated by the   Pharmaceuticals and Medical Devices Agency (PMDA) , has become the cornerstone of the country’s drug submission process. In recent years, Japan has made substantial updates to its eCTD requirements to improve submission efficiency, enhance regulatory transparency, and reduce approval times. Here’s everything you need to know about Japan’s eCTD update and how it impacts the pharmaceutical industry. What is eCTD and Why It Matters in Japan? eCTD is a standardized format for the submission of regulatory documents to health authorities. In Japan, the PMDA implemented eCTD to streamline and digitize the process of submitting pharmaceutical dossiers. The transition from paper-based submissions to eCTD has not only enhanced submission quality but a...

  Introduction Brazil is taking significant steps to modernize its regulatory framework for biologics and biosimilars. In 2024,  the Brazilian Health Regulatory Agency (ANVISA)  published crucial updates that laid the foundation for more harmonized and science-based oversight. With 2025 shaping up to be a transformative year, stakeholders in the life sciences sector need to stay informed and proactive. 2024: Strengthening regulatory foundations RDC 875/2024: Improvements in the biosimilars pathway Issued in May 2024, RDC 875/2024 introduced updates to the comparability pathway for biosimilars. The regulation allows: Exemption from certain non-clinical and clinical studies when scientifically justified Use of international reference products approved by Authorities Recognized as Equivalent (AREEs) when local comparators are not available and provided that they are manufactured by the same manufacturers of the medicine registered in Brazil or that they have carried out brid...

  Introduction Brazil is taking significant strides toward modernizing its Regulatory framework for  biological products and biosimilars . In 2024, the  Brazilian Health Regulatory Agency (ANVISA)  introduced critical updates that laid the foundation for more harmonized, science-based oversight. With 2025 shaping into a transformative year, stakeholders in the life sciences sector must stay informed and proactive. 2024: Strengthening the Regulatory Foundations RDC 875/2024: Enhancements to the Biosimilar Pathway Issued in May 2024, RDC 875/2024 introduced updates to the  comparability pathway  for biosimilars. The regulation allows for: Waiving of certain non-clinical and comparative clinical studies when scientifically justified Utilization of  international reference products  approved by Authorities Recognized as Equivalent (AREEs) when local comparators are unavailable and since they are manufacturing at the same manufacturers as those of the ...