Draft guideline
Subsequently, the assigned rapporteur(s) prepares the draft text taking into account the comments received during the consultation period on the concept paper (if any). The (co)-rapporteur may consult appropriate experts to provide input. The guideline is further developed to a point where the views of the members of the responsible working party (WP) are clearly presented, the draft guideline is submitted for adoption at the main scientific committee - Committee for Medicinal Products for Human Use (CHMP) of the draft document (guideline, Q&A, reflection paper etc) for release for consultation[3].
Providing comments is not exclusively for the medicine and vaccine developers and manufacturers, but as important is to involve a wide range of other stakeholders. In general comments could be received from:
The WHO Good Regulatory Practice Guidance emphasizes the importance of transparency [8]. If consultations have been conducted throughout the development of the proposal, a summary should be prepared of the comments received and how they were taken into consideration. This feedback provides transparency and credibility to the consultation process and increases the efficiency and effectiveness of regulation likelihood of regulatory success, supports shared learning and alignment. Therefore, all comments are carefully considered and discussed by the rapporteur and/or drafting group responsible for the guideline. Comments provided by stakeholders are systematically published on the EMA website, unless they contain commercially confidential information and/or the author has specifically objected to their publication. The publication of the received comments will include an overview explaining the rationale behind the acceptance or non-acceptance[3].
Table 1. Public consultation timelines