COFEPRIS Reliance Pathway: Mexico Regulatory Update 2025
Modernization of the COFEPRIS Regulatory Framework: Introduction of a Reliance Pathway Diario Oficial de la Federación (DOF) published a new […]
Digital Health In Regulatory Affairs
The old traditional methods of diagnosis, treatment and prevention have certain drawbacks such as late detection of non-symptomatic diseases, lesser
Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other
Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in
CDSCO Manufacturing License for Cosmetics in India
In India, the cosmetic industry is burgeoning, with a plethora of domestically manufactured products gracing the market every day. However,
Registration of Biologics in Malaysia (NPRA)
Biologics have emerged as a significant treatment for various diseases in Malaysia. With their increasing relevance in addressing chronic diseases
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan’s biosimilar business, with a market value of $140 million, accounted for just
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
System and Procedure Packs in Accordance with EU MDR
In today’s healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools