Since the start of the COVID-19 health crisis, the FAMHP has given the highest priority to requests for national scientific-technical advice (STA) on medicines against COVID-19. The National Innovation Office and Scientific-Technical Advice Unit uses accelerated timelines for requests regarding medicines that prevent or cure COVID-19 infections. These timelines are crucial to support accelerated clinical research on new medicines against COVID-19.
The FAMHP has formalised the new procedures for the accelerated processing of applications for national STA for medicines against COVID-19. A formal request for accelerated STA can be submitted according to the provisions in article 4 of the Law of 8 February 2022. These provisions apply to national STA requests with regard to the research and development of medicines for human use that prevent or cure COVID-19 infections (including combination products that fall under the category of medicines).
The accelerated STA procedure applies to both initial and follow-up requests. Requests for written technical-regulatory advice (STA Type I) are processed within a maximum of fifteen calendar days. This period of twenty calendar days starts from the date on which the STA request can be declared admissible. This is done according to the procedure described in article 3 of the Law of 7 April 2019.
Requests for national scientific advice (STA Type II) and mixed scientific and technical-regulatory advice (STA Type III) are processed within a maximum of twenty calendar days during a STA meeting with the applicant. This period of twenty calendar days starts from the date on which the STA request can be declared admissible. This is done according to the procedure described in article 3 of the Law of 7 April 2019.
The applicant can choose to follow the accelerated procedure without prior consultation with the FAMHP and may request a written advice only. In this case, the written advice is given to the applicant within a maximum of twenty calendar days.
Simultaneous national scientific advice
The accelerated STA procedure can, if justified, also be applied to the pilot procedure for simultaneous national scientific advice (SNSA). This is done in cooperation with a second medicines authority, provided the latter can manage the same accelerated timelines.
The request for accelerated STA is announced in advance with an intent to submit letter.
- At least one week in advance for STA type I.
- At least two weeks in advance for STA types II and III.
The letter of intent contains the following information:
- the planned submission date,
- brief background information on the nature of the medicine,
- the nature of the questions raised and submitted for advice,
- the specific context of the accelerated STA request.