On January 14, the National Administration of Medicines, Food and Medical Technology (NAMFMT) created the Integrated Bioavailability Program. Its objective is the development and application of bioinformatics models for the analysis and evaluation of the toxicity, kinetics and safety of drugs and medicines. Also, on January 11, NAMFMT made available the criteria for making applications to register medicinal specialties that require demonstration of bioequivalence and explained that, when two laboratories use the same active ingredient, a demonstration of bioequivalence may be requested between them.

In addition to promoting the development of bioinformatics models, the program created under provision 271/2019 will actively participate in the review of the regulatory framework and technical specifications relating to bioequivalence, bioavailability, in-vitro equivalence and bio-exemptions.  

In addition, NAMFMT published the criteria for applying for registration of medicinal specialties that require demonstration of bioequivalence in the Register of Medicinal Specialties (RMS) and on the list of New Pharmaceutical Forms / Concentration. This decision, contained in an official notice, refers to medicinal specialties composed of the pharmaceutical ingredients covered by the six provisions summarized here.

Finally, the national authority also stipulated through a second official notice that, when two or more laboratories are holders of a medicinal specialty with the same active pharmaceutical ingredient, either of them may apply to the other one for recognition of the bioequivalence demonstration made.