INFARMED-National Authority of Medicines and Health Products, I.P. (INFARMED, IP) defined in 2010 as part of its strategy modernization, the mandatory adoption from 1 January 2012, the eCTD format in the submission of new applications for authorization the market (AIM) of medicines for human use. the mechanism adopted in 2010 was a balanced solution and agreed with strategic partners, and provided a transition period and maintenance, even after the beginning of 2012, then accepted formats INFARMED, IP, when they had been adopted by applicants when applying for AIM. The use of submissions in eCTD format post-AIM, although recommended by INFARMED, IP assigned to the initiative of continued MAHs. Towards the beginning of 2012, it appears that the majority of EU member states did not adopt the eCTD format as required format.
Given the context of the use of the eCTD at European level, either by regulatory authorities or by the pharmaceutical industry, INFARMED, IP intends to continue to permit the use, from January 2012
Nees also the format in the submission of applications for marketing authorization for all types of procedures.
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