TIMELY ACCESS TO INNOVATION
AIFD Health Sciences Policies Strategic Management Committee had established two cardinal priorities for the years 2019 and 2020 for the “Timely Access to Innovation” area, one of the six strategic priorities areas of the Association.
- Harmonization of national regulations with international standards in the licensing processes of Biotherapeutics, Orphan Medicines and Advanced Therapy Medicinal Products.
- Providing timely access to innovative treatments and improvement of scientific review processes at all license evaluation steps
The following strategic priorities are established at Task Forces level for these focus areas.
Biotherapeutics and Bioequivalents Task Force
(Biotechnological Medicines TF)
Biotherapeutics and Bioequivalents Task Force focused on three areas during 2020.
- Contributing to the creation of Biosimilar regulations in line with international standards
- Advocating for a clear policy on the replacement, substitution and traceability of biosimilar drugs
- Create a focus on innovation policies on biotechnology field in order to support Turkey's role as a global competitive player
Regulatory Affairs Task Force
Regulatory Affairs Task Force was active in 2020 on the following four areas:
- Advocating the enhancement of the quality and transparency of scientific examination in the licensing process
- Identifying the problems slowing the process of timely access to innovative drugs
- Making AIFD positions more effective with up-to-date data to align national regulations with international standards
- Supporting TITCK's goal of becoming a recognized reference authority
Rare Diseases Task Force
Rare Diseases task Force focused on the three areas enumerated below:
- Contributing to the creation of a national policy on rare diseases
- Advocating for an Orphan Drug Regulation in line with international standards
- Contributing to the increase of public awareness on rare diseases
PANDEMIC ERA
As the COVID-19 global epidemic was detected as of March in Turkey, we continued our cooperation and communication with all our stakeholders in order to prevent disruption of drug procurement, licensing and inspection processes. In this context, sector coordination meetings were held with TITCK at regular intervals. Problems identified by AIFD companies along with the suggested solutions were conveyed to the Authority during these meetings.
Between April and November, a total of 9 online coordination meetings were organized with TITCK Licensing and Inspection Departments. In these meetings, information and suggestions on the urgent issues requested by AIFD to be taken into the agenda regarding licensing and GMP audits during the pandemic process were shared as well as other important issues such as the general working procedures of the departments, the flexibility that can be applied in pandemic conditions and the working order of the commissions.
A total of 11 online meetings at regular intervals were organized with AIFD members in order to convey information received from TITCK Department Heads and other important announcements.
Among the flexibilities implemented during the pandemic period through AIFD initiatives, the most important gain for the sector was the flexibilities applied within the guideline published by TITCK on GMP Inspections Abroad on 12 June 2020.
In addition to the online coordination meetings held during the pandemic process, we sent our official opinion letters to the relevant units of TITCK on the following 10 issues.
09.04.2020 Urgent Issues Regarding Regulatory Affairs During the Pandemic Period
09.04.2020 AIFD Proposals for GMP Inspection Process Due to the Pandemic
04.05.2020 AIFD Opinion Regarding Delays in Registration Process of Innovative Products
04.05.2020 AIFD Proposal to Alleviate the Failure of Treatments of Patients with Chronic Diseases Receiving Their Treatment in Hospitals / Health Centers Due to the Measures Taken related to COVID-19 Outbreak
05.05.2020 Priority Problems and Solution Proposals Regarding Audit Processes
12.05.2020 AIFD Recommendations Regarding Pharmacovigilance Processes Due to Pandemic
04.08.2020 Current Problems in AIFD Licensing Processes
12.08.2020 Undertaking for Analysis, Industry Opinion
29.09.2020 AIFD Opinion on the Transition of Scientific Advisory Commissions to Online Working System
07.10.2020 AIFD Recommendations for Expeditious Approval of COVID-19 Vaccines in Turkey
