On February 18th, 2022, Global Regulatory Partners Inc,) achieved a huge milestone for the registration of a new vaccine in Mexico, by receiving a positive opinion from the New Molecule Committee (NMC) in Mexico.
In Mexico, the health authority (Cofepris) requires pharmaceutical and biotechnology companies to have a consultation meeting with the (NMC), and received their positive opinion before submitting the registration dossier for any new drug or biologic to them.
Global Regulatory Partners’ team in Mexico spent over 5 months preparing for the NMC consultation meeting. The main activities included, submitting a meeting request, preparing and submitting the meeting package to NMC, coordinating all the logistic related to the conduct of the meeting and attending the meeting.
The vaccine that was reviewed by the NMC is a smallpox vaccine, manufactured by a global pharmaceutical company that appointed Global Regulatory Partners Mexico as a local representative in Mexico, who will handle all the regulatory activities for them in this country.
“Receiving a positive opinion from NMC is huge milestone for our company in Mexico. It will allow us to shorten the registration process of our smallpox vaccine in Mexico by 6 months and make it available to Mexican children sooner than later,”
BLOG: New Molecule Committee in Mexico
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS.
Case Study 57: Registration of Vaccines (Biologic) in Mexico
European drug manufacturer is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. The Client wanted to market their product in Mexico and was looking for a local partner with experience with vaccines and biologics, that can represent them in Mexico.
About Global Regulatory Partners
Global Regulatory Partners, Inc is a leading provider of tailored Regulatory Affairs, Clinical and Compliance services for pharma, biotech and medical device industries worldwide.
We support our client from early stages of their products’ development, through clinical development, products’ registration, and lifecycle maintenance, by providing them tailored regulatory affairs, clinical and compliance services that meet their needs and facilitate their access to different markets.
Global Regulatory Partners. Inc has 6 offices in 6 strategic market countries (USA, Brazil, Mexico, Japan, China and South Korea) and more than 600 satisfied clients worldwide.