Regulators analyze reform of drug stability studies
14 febrero 2018

The public consultation of the Brazilian regulatory agency ANVISA (National Agency for Sanitary Surveillance) of the regulations established by the Stability Testing protocol for active pharmaceutical inputs (IFAs) and generic or similar drugs is open.

These Stability Testings are carried out to verify that the products maintain their quality, efficacy and safety characteristics throughout their validity period. The studies have two ways of being carried out, one of long duration – which takes two years or more to be completed – and another accelerated – which takes 6 months to be completed.

At present, the regulations of Stability Testings have several gray spots, encouraging the subjective interpretation of the regulations. In turn, there are 4 regulations in force in Brazil that regulate these studies, which makes their regulatory predictability difficult.

In addition, the requirements for Stability Testings of synthetic drugs are provided by the Q1 guideline of the International Council for Harmonization – ICH. ANVISA assumed the commitment of harmonization with this guide when it entered the board, giving an estimated time for its harmonization in June 2018.

In the Brazilian case, the temperature and humidity conditions of the study will not be respected, due to the fact that the climatic conditions of the South American state are different to those verified in the member countries of the ICH at the time of the elaboration of the Q1 guidelines.

Next steps

The public consultation will be open until April 9, 2018. Then, the comments received will be analyzed and technical feasibility studies will be carried out, with the end of presenting a final proposal that will be evaluated by ANVISA’s management and promulgated in the Official Journal of the Union before June of this year – in compliance with the entity’s commitment to the ICH.

 

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