Latin America
The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
El Salvador has approved a law that will establish a new regulatory body responsible for authorizing medicines and setting prices.
Mexico aims to speed up the registration of generics and biosimilars.
Moves to widen GMP certificate recognition are in line with World Health Organization recommendations on Good Reliance Practices and with the Mexican government’s strategy for regulatory certainty for the pharmaceutical sector, says the country’s drugs regulator.
Increasing the capacity for local development and production of medicines and other health technologies in Latin America and the Caribbean is among the objectives of the new deal.
The number of regulators formally agreeing to work towards creating a Latin American regulator is growing.
Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.
Regulators in Mexico, Colombia and Cuba have affirmed plans to create a new Latin American and Caribbean Medicines Agency.
The lack of availability of coronavirus vaccines in many less well off parts of the world is an open invitation to criminals seeking to sell falsified or substandard versions. Many instances of vaccine theft and diversion have also been found.
Sanofi and GSK have restarted their Phase II vaccine study, Australia is allowing public advertising of coronavirus vaccines, and Sputnik V has landed in Mexico.
Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy.
While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective and more-easily deliverable option.
Tuberculosis or cancer, sterility assurance or shortages, the choices come at you fast; Takeda, Wintac, Banco Vida updates.
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
Public health advocates say that commercial concerns must take a back seat to health interests if COVID-19 technologies are to be made available to those who need them. But industry says that relaxing IP protections is not the solution and that many companies have already invested significant amounts of money in potential new treatments and vaccines.
Intellectual property rights are under the microscope as countries prepare to provide affordable and timely access to pandemic technologies.
USMCA is looking more and more like a win for generic firms, who hope it will be template for future trade agreements.
Stripping the revised USMCA deal of provisions to strengthen IP rights for biologics will worsen market difficulties in Canada caused by changes to the drug pricing regime, says industry.
Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.