Cofepris – New Regulatory Safety Strategy for Medical Devices

Cofepris has launched a Regulatory Safety Strategy for medical devices, aimed at strengthening regulation and collaboration with companies in a market worth more than 16 billion dollars
Anvisa – Changes in RDC 821/2023 and IN 258/2023

Anvisa informs that RDC 821/2023 and IN 258/2023 come into force November 1, simplifying the qualification of impurities in pharmaceutical products.
RDC 653: Changes to the transportation and storage of medicines

RDC 653 introduces important corrections to the management of temperature control of goods and the period of application of the rules.
Anvisa warns about aesthetic products used in injectable form

Anvisa warns that aesthetic products intended for injectable procedures cannot be regulated as cosmetics.
Cofepris authorizes new influenza vaccine for seniors

Cofepris, Mexico’s regulatory agency, authorizes new influenza vaccine for seniors, plus 165 new health supplies.
Sindusfarma calls for new regulatory framework for drug labeling

The central issue raised by sindusfarma is the difficulty of inserting the aforementioned phrases into primary packaging.
Infarmed authorized innovative medicine for several types of cancer

Pembrolizumab can be used, among others in the treatment of metastatic triple negative breast cancer.
Warnings to prevent antibiotic breakouts this winter

At stake are medicines intended for the treatment of respiratory infections.
Cofepris detects 7 new irregular drug distributors in the country

Cofepris performs strict surveillance to verify that companies do not violate the regulation.
Our team were present at FISA in São Paulo!

The largest innovation meeting for the ingredients, food and beverage sector in South America.