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Latin America Roundup: EU Commits Funds Toward Regional Regulatory School

The European Union has committed 1.5 million Euros to the creation of a Regional School of Sanitary Regulation, a project spearheaded by Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS). The funds will be administered by the Pan American Health Organization as part of an ongoing effort by Mexico, Colombia, Cuba and others to strengthen regulatory capacity in Latin America and the Caribbean, including through training of more professionals. The agreement was signed in Mexico on 25 August by representatives of the EU and PAHO, as well Alejandro Svarch, COFEPRIS commissioner. The school, to be based at the Universidad de la Salud in Mexico City, will provide “a solution that strengthens regulatory capacities, promotes regulatory convergence and creates spaces for continuous training in the Americas,” COFEPRIS said in a statement, adding that branches will be opened in other countries as well. The school is expected to open in 2024, the agency said.

Mexico’s COFEPRIS reinstates scientific advisory board, citing past corruption

Mexico’s COFEPRIS agency announced on 22 August that it had reinstated its scientific council (consejo científico), an advisory board made up primarily of academic scientists that had not convened in recent years.  

“We are sure that the scientific council … will base its decisions on knowledge,” commented Raquel Buenrostro, Mexico’s economic secretary, at an event to mark the council’s reinstatement. “The pharmaceutical industry is strategic in our country; it is a strong industry that is growing, and it is also an industry that exerts pressure.” The council and its good practices subgroup will help hew to international standards, Ms. Buenrostro said, to assure “that the products [approved] are scientifically the most appropriate for the population.”

Speaking at the same event, COFEPRIS commissioner Alejandro Svarch blamed past governments for promoting a culture of favors and influence peddling at COFEPRIS that had marginalized the council’s work.

Mexico accepts other countries’ GMPs to facilitate import of biologics; claims doubling of device approvals

Citing the need to improve access to vital medicines, COFEPRIS is allowing foreign makers of biologics sold in Mexico to forego obtaining a Certificate of Good Manufacturing Practices (GMP) from the agency before their products can be released in the country. Instead, as of 23 August, they may present GMPs issued by other health authorities accredited by the World Health Organization (WHO), PAHO, or members of the Pharmaceutical Inspections Cooperation Scheme (PIC/S) in lieu of a COFEPRIS certificate.

The new rule is intended to complement ongoing efforts by COFEPRIS, announced earlier this month, to promote local manufacturing of biologic and biosimilar products, according to a statement from the agency. Together, “these actions are an important step to ensure that Mexicans have access to safe, effective, and high-quality biotechnological and biosimilar medicines, and reinforce the health authority’s commitment to the health of the entire population,” the statement said. Days earlier, in a separate announcement, the agency said it had authorized 1,588 new medical devices in 2023, representing an increase of some 125% from 2022 and an 88% approval rate. 

Argentina sees more oncology trials

Clinical trials of oncology therapies increased in Argentina from 2018 to 2022, according to a report issued by the country’s medicines agency. The report, published in the scientific magazine of Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT), found that the number of oncology trials grew by 28% over this period, and that oncology represented the leading specialty among all clinical trials (180 of 776 trials authorized). Some 70% of the oncology studies used innovative or nontraditional designs “based on the presence of specific biomarkers” and intended to promote “efficient and accelerated development of drugs,” the report found. Most of the studies (71%) were Phase 3 trials, while 10% had combined-phase designs, mostly Phase 1/2 trials. Investigational therapies used in oncology trials comprised mostly monoclonal antibodies (58%) followed by small molecules (32%).

Venezuela bans vaping, following Panama and Mexico

Officials with Venezuela’s health ministry announced a national ban on the import, use, promotion or sale of electronic cigarettes and vaping products, including those that do not contain nicotine. The law, enacted 1 August, includes mandatory signage on public transit reminding users of the ban, which follows similar, recent prohibitions enacted in Panama and Mexico, where COFEPRIS has issued a number of alerts related to electronic nicotine delivery systems and mounted elaborate public health campaigns to discourage their use. The Latin American anti-vaping laws, reflective of the World Health Organization’s dim view of the products, have been criticized as difficult to enforce, and potentially encouraging of abuses by public officials seeking bribes. 

Brazil’s ANVISA updates on melatonin for children, medical device imports

Brazil’s National Health Surveillance Agency, ANVISA, said 24 August that it had banned a specific melatonin-containing supplement marketed for use in children. Melatonin has “not been evaluated for safety for use by children in food supplements and, therefore, is not allowed for this population group,” the agency said in a statement.

Additionally, on 25 August, the agency said it had made changes to its rules on medical devices to allow the import of devices manufactured up to 5 years before the date of their regularization by the agency. Brazil is Latin America’s largest market for medical devices.

Source : Regulatory Affairs Professionals Society