In January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched the Accelerating Clinical Trials in the EU (ACT EU) initiative. This initiative consists of ten suggested actions for sites, sponsors, and clinical research organizations (CROs) to take over the next three years, leading up to the full implementation deadline in January 2025. The goal of ACT EU is to facilitate the implementation of the EU CTR and CTIS and accelerate clinical trials in the EU.
The medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). There are different Regulatory pathways for the registration of medical devices in Mexico. Manufacturers may opt for Standard Review or Equivalency Review and may or may not opt for the third-party Reviewer.
Are you currently submitting eCTDs (electronic common technical documents) to European Region (EU)? Or planning for the same in near future? Then we suggest it’s time to pull up your socks as the EU is taking its turn in 2016. As we could decode the details from EU M1 eCTD specification – V 3.0, which was published in the last quarter of 2015, the final version is set to take effect from 1st July 2016 and is set to be mandatory from 1st October 2016.
What companies should realize about the new specification, Module 1 change, is the complexity for it’s: