Regulatory Authority Questions/Requests
The key stakeholder in the pharmacovigilance system from the
decision-making perspective is health authorities, also known as regulatory authority,
regulatory agency, competent authority, or health authority. For the ease of understanding,
we will use RA as a term.
RA is the decision-making body for that particular country
regarding the product and patient safety pertaining to the particular product.
We are already aware of key RA e.g. FDA, EMA, CDSCO, MHRA etc.
Any RA may have a routine channel of discussion with MAH for
various activities, or they may request additional or ad hoc data for ongoing evaluations
about products. We will discuss only about pharmacovigilance related requests
or questions from the RA.
Routine requests for communication between MAH and RA:
·
Application for approval of products known as a marketing
authorisation application
·
Renewal of product approval
·
Product label updates
·
Aggregate reports (PSUR , DSUR,PADER)
·
Risk management plan
·
Safety communication
·
Pharmacovigilance System Master File (PSMF)
Additional requests
·
Any data clarification requests about the above
submissions, e.g. line listings, study reports, etc
Ad hoc requests for communication between MAH and RA
·
Device-related or combination product-related
questions
·
Technical complaints or product quality issues
·
Individual case safety reports related
·
Urgent safety communication for signals
·
Signal notifications
·
Direct healthcare professional letters
·
Risk minimisation measures related
·
Study related e.g. protocol, ICF, conduct of
study, etc
·
Inspection-related- follow-up to conducted
inspections
·
Product benefit risk assessment evaluation of off-label
use, abuse, misuse, etc
Common reasons for additional requests include: Frequently
observed issues include new or unanticipated safety risks, gaps in efficacy
evidence, requests for additional studies, and deficiencies in product quality,
analytical controls, or manufacturing processes.
Preparation of response:
A request for additional data requires only coordination between
different functions and a clear process, including a template to respond.
A request for additional data or analysis may need more time
and a clear process.
Every MAH has an internal SOP on managing RA-related requests
with timelines and templates with clear roles and responsibilities of each function.
An RA response from MAH should be concise, clear and factual,
and hence it needs to be verified by reviewers and approvers.
A RA response with an action plan regarding a signal or a
risk minimisation measure should clearly define the implementation and
timelines. An RA response on label changes should clearly define the data to
support this. An RA response regarding the assessment on a off label use, misuse
or abuse or any such topics should clearly define the MAH position.
An RA response usually consists of the – Formal request from
RA, details, background, evidence or analysis by MAH, conclusion, references
and an appendix consisting of relevant documents e.g. label, data listings,
implementation for risk minimization measures, DHPC draft, etc.
Written by:
Dr.Shraddha Bhange.
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References:
1.
Guideline on good pharmacovigilance practices
(GVP) Module II – Pharmacovigilance system master file
2.
https://link.springer.com/article/10.1007/s43441-022-00430-z
3.
https://www.fda.gov/files/about%20fda/published/Good-Review-Practice---Refuse-to-File.pdf
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