The Brazilian health surveillance agency Anvisa opened public consultation on the proposed text of the Brazilian rules adopting the Good Manufacturing Practices for Drugs under the Pharmaceutical Inspection Co-operation Scheme, or PIC/s, which has already been adopted in 47 countries .
It is Public Consultation No. 653, which was published on the official gazette DOU on May 27. Contributions will be accepted for 60 days as from June 3, i.e., August 1.
During this time, the public in general is allowed to provide remarks and suggestions on the impact that such rules may have on the already existing drug manufacturing process (as regulated by RDC 17/2010).
One of the rules under discussion in the Public Consultation determines that the Good Manufacturing Practices for Drugs under the Pharmaceutical Inspection Co-operation Scheme are to be considered the minimum requirements to be imposed on drug manufacturing in Brazil. The new rule is to apply to all drugs without restriction and will cover from pharmaceutical quality assurance systems, document drafting and monitoring, contractor’s activities, and self-inspection, to the proper systems and procedures to be used in registering complaints and product recalls.
The other rules that are object of the Public Consultation deal with either certain specific aspects of the good manufacturing practices for drugs or specific product categories such as experimental drugs, blood products, and phytotherapeutic drugs.
The new rule states that the Good Manufacturing Practices (GMP) refer to a quality management system assuring that products are consistently manufactured and monitored according to quality standards which are suitable to the intended use, as imposed by the Anvisa registration.
Contributions may include: (i) suggesting improvements on the text with a view to a better translation and comprehension, so that the Brazilian rule reflects the original meanings under the PIC/s; (ii) informing the need to extend deadlines applicable to certain new requirements; (iii) clarifying doubts on the meaning of any section, informing the lack of full comprehension of any aspect of the rule, such as Anvisa’s interpretation of a certain clause; and (iv) proposing a change to the draft text with suggestions on prerequisites to the new rule, if the rules as provided for the in draft text are found to be not enough.
Important to note is that the objective of the new rules is not to create an entirely different guide, but else to adopt in Brazil the rules which are already used in 47 countries.
Upon conclusion of the Public Consultation, Anvisa will review all contributions and may carry out discussions with bodies, entities and interested parties with the purpose of providing more information which is necessary for further technical discussions and the final decision by the Board of Directors.
