FDA INTERACT Meetings: Early Strategic Alignment for Innovative Therapies
At Global Regulatory Partners (GRP), we understand that early regulatory strategy plays a critical role in the success of innovative drug development programs. For companies developing novel therapies—especially those with limited regulatory precedent—the FDA’s INTERACT meeting represents a valuable opportunity to engage with the Agency at a formative stage.
INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER- and CDER-Regulated Products) is designed to support early, focused dialogue between sponsors and FDA reviewers. When strategically utilized, it helps identify potential risks, refine development strategies, and establish a solid regulatory foundation before significant investments are made.
Leadership Transition at COFEPRIS: Regulatory Consistency Risks and the Need for Stability
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s national regulatory authority responsible for protecting public health by overseeing medicines, medical devices, food products, tobacco, and other health-related inputs. COFEPRIS plays a central role in ensuring product safety, authorizing market access, and establishing technical regulatory requirements across the country.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
Regulatory Challenges faced by Cosmetic Companies
Cosmetics is a dynamic industry, with new novel products ready to market it puts significant pressure on companies to understand global regulation and registration processes in order to reach consumers and markets globally.
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.