Extraordinary Newsletter n°17/2017
Informativos . 23/06/17
It was published on 2017.06.19, Official Gazette, the Public Consultation No. 355/2017, which full text was made available on 06.22 and aims to establish new procedures for the approval of clinical studies, good manufacturing practices certificate and registration of drugs intended for treatment, diagnosis and prevention of rare diseases. The deadline for contribution is 30 days as from 2017.06.27.
The main innovations comparing to the current procedure regarding drugs’ registration is as follows:
– Rare disease is that one that affects up to 65 individuals out of 100,000 individuals, as defined by the National Policy on Comprehensive Care for Individuals with Rare Diseases;
-ANVISA shall determine whether it considers the disease rare previously to submission of any request related to the new product. This conclusion shall be made in up to 30 days as of the request of designation of the drug for the rare disease. Besides, ANVISA itself may assign drugs for rare diseases.
– Mandatory meeting with ANVISA prior to dossier submission.
– The deadlines to answer deficiency letters diminished from 120 days to 30 days.
– Deadline of 45 days for checking the fulfillment of ANVISA’s deficiency letters.
– It is allowed submission without the need for proof of registration in country of origin.
– Decision in the request for GMPc, added to ANVISA’s statement regarding the designation of rare disease drugs, with a conclusive opinion within 120 days of the protocol.
– Possibility of acceptance of safety and efficacy reports containing data from phase II studies completed and phase III studies in progress, or without the submission of phase III clinical trials, when such studies are not feasible.
– Permission to suppress the quality control in Brazil of imported drugs, if the quality control is performed by the manufacturer of the drug and a summary report of the qualification of the transportation system is presented in the submission.
– The registration request can be instructed using the format Common Technical Document (CTD), as per Guide M4 from the International Conference on Harmonization (ICH).
– Possibility of admission of data complementation and additional evidence after registration of the drug, by means of a signature of an agreement between ANVISA and the company. If the commitments are not fulfilled the registration may be canceled.
– Drugs registered by the criteria of the new resolution will have 365 days to be marketed, counting from the date of publication of the registration. If they are not commercialized within the established period, they will have the registration canceled by ANVISA.
Click here to download the full text of the Public Consultation CP No. 355/17 in English (free translation).