COMPLIANCE WITH INTERNATIONAL STANDARDS & LEGISLATION
TITCK's Vision to Become a Reference Authority
Providing full support to TITCK to make it a global brand and to become a reference authority has continued to be one of the strategic priorities of Health Science Policies SMC.
After TITCK was accepted as an ICH observer member in 2018, AIFD made many attempts to support TITCK in the entire process since the application process.
TITCK's application for ICH full membership was approved unanimously at the Council's meeting on 27 May 2020. Turkey, will play an active role in global drug development and manufacturing processes. TITCK has taken its place among the few authorities on pharmaceuticals. TITCK will not only comply with ICH guidelines, but will also contribute to the creation of these guidelines.
The second ICH survey for observing, evaluating and monitoring the compliance of the member authorities with ICH guidelines was launched in December in 2020.
ICH carries out this survey with the Center for Innovation in Regulatory Science (CIRS), with which TITCK collaborates in different projects. TITCK as a full member of ICH, will also participate in this survey. Authorities and industry representatives also participate to the survey. After the finalisation of the survey, the results are planned to be shared with all participants and presented at the ICH General Assembly to be held in 2021.
Meetings were organized by AIFD, EFPIA and IFPMA among member companies in order to inform companies that will participate in the compliance studies of ICH standards, which started in 2019, about the process and to increase the harmony between members. During these meetings, the representatives of EFPIA and IFPMA briefed participants about the full compliance process of ICH.
In support of the ICH full compliance process, AIFD made a call on 15 October to AIFD companies for the ICH Working Groups operating within IFPMA and applications were collected to ensure AIFD representation in the relevant groups. A total of 10 AIFD experts were selected for the IFPMA ICH Working Groups below.
- E2D(R1) EWG
- E19 EWG
- Q9(R1) WG
- E6(R3) EWG
- E8(R1) EWG
- E20 EWG
- M13 EWG
- Q2(R1) / Q14 EWG
We believe that the participation to IFPMA ICH groups will be an opportunity for AIFD to smooth the ICH harmonisation process of Turkey and it will improve communication between all stakeholders associated with ICH.
Draft Licensing Regulation and Guidelines
No progress was achieved in 2020 in the updating of The "Regulation on Licensing of Medicinal Products for Human Use", which was initiated in 2017 aimed to comply with the relevant legislation of the European Union.
We continued to express, both in academic and administrative platforms, our views and objections to the articles of the Draft Licensing Regulation that diverge from the EU legislation and contain significant incompatibilities with the acquis. We stated that the licensing regulation should be at international standards and be based on science.
We have shared at every opportunity, verbally and in writing with the top management of both the TITCK and of the Ministry of Health that we are fully behind the goal and vision of TITCK to become a globally accepted, respected reference institution that internalized international standards, and that we will make every effort to support it.
In this context, the basic regulation provisions objected by AIFD are the following:
- "Original" medicinal product and "Generic" medicinal product terminology should not be changed
- Inclusion of the term "High similarity" in the definition of "Biosimilar Product".
- Specifying the re-evaluation criteria specified in the definition of "Production Place"
- Shortened applications should not be accepted during the "Data Exclusivity" period
- Requesting clinical trials in abbreviated applications of "Combined Products"
Draft Variation Regulation and Guidelines
The finalisation of the evaluation of regulations and guidelines related to the variations of licensed pharmaceuticals for human use in line with the international standards will be an important contribution to assure supply continuity, patient access and simultaneous evaluation with international authorities.
It was observed that there are significant divergences between the variation evaluation and approval processes currently implemented in our country and the international standard methods; our observations and proposals to eliminate the divergences in the processes were submitted to the Agency in October with an official letter.
