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:
- Governmental organisations in Member States of the EEA/EFTA countries,
such as national regulators or HTA bodies;
- Other regulatory authorities (e.g. FDA, European Directorate for the
Quality of Medicines (EDQM) , other (V)ICH partners);
- European industry associations;
- European scientific/academic societies and patient/consumer
groups/health care professionals;
- Other interested parties.
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