Belgium agency tackles delays in responding to simple pharma queries
This article was originally published in SRA
Belgium's Federal Agency for Medicines and Health Products, the FAMHP, is taking steps to reduce the huge delays that drug companies face in getting a response from the agency's call center to their simple questions, such as the status of an application and other queries related to product registration.
"Call Center Registration" is a unit of the FAMHP that was created in 2006 to answer simple product registration-related queries from the pharmaceutical industry so as to decrease the number of questions directly posed to the FAMHP's file managers, an agency spokesperson told Scrip Regulatory Affairs.
The call center acts as a go-between between the pharmaceutical industry and the registration department, and is supposed to answer all queries within 10 working days irrespective of whether these were submitted by email or over the phone. A spokesperson for the Belgian Pharmaceutical Industry Association confirmed to SRA that there has been "a huge backlog in the past", but could not offer details about "to what extent these are still continuing".
However, staff shortage at the call center last year resulted in companies facing delays in getting a response to their queries relating to: the status of submitted applications; offering regulatory guidance concerning the submission of new authorization/registrations, variations, renewals and parallel imports; offering guidance on the correct contact person or department within the FAMHP; offering information regarding authorized medicinal products; and providing contact details for other agencies or public services for various inquiries regarding authorized medicinal products.
Since the call center was established, the number of inquiries it receives has increased substantially. This, together with unexpected staff absences in 2014, led to companies facing long delays in getting a timely response to their queries.
To deal with this problem, two supplementary FTEs (full time equivalents) were assigned to the call center in November last year, and a new procedure was put in place to "absorb" the delayed queries. Specifically, these queries/requests:
- concern variation dossiers for which a correction of leaflet/summary of product characteristics (SmPCs) is necessary – the call center staff will contact the applicant since publication of SmPCs and leaflets on the FAMHP website are considered as high priority;
- were submitted between September and December 2014 and will be gradually assigned to FAMHP employees so that they may contact the applicant to ascertain if the query/request is still applicable; and
- date before September 2014 for which no reminder was received before 30 January 2015 – these will be considered as irrelevant and will be closed.
All new queries will be assigned to FAMHP employees as soon as possible. For these, the applicant company will receive an acknowledgement from the registration mailbox and an answer will be provided within the respected term of 10 working days, the agency said.
The FAMHP spokesperson clarified that staff shortage at the call center did not interfere with the actual processing of new marketing authorization applications or with updating existing authorizations.
References
1. Call Center “registration”: Expansion team in 2015, 21 January 2015, http://www.fagg-afmps.be/en/news/news_call_center.jsp?referer=tcm:292-262062-64