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LEGISLATIVE DEVELOPMENTS ON R&D & INNOVATION IN 2022

17.01.2022

With the announcement made by TITCK on January 17, 2022, the application document types for Clinical Research Applications have been updated.

10.02.2022

“The Guidance on Phase I Clinical Trials Centers” was published.

24.02.2022

'Guideline on the Procedures and Principles Regarding the Studies to be Conducted with the Request of the Supporter within the Scope of Revolving Fund Management' was published.

05.05.2022

The TITCK Department of Clinical Trials published an announcement on May 05, 2022, on "Measures to be Taken in Clinical Trials Due to COVID-19 Pandemic".

30.05.2022

The Ministry of Treasury and Finance (Revenue Administration) published the General Communiqué on Law No. 746 on Supporting Research, Development and Design Activities (Serial No: 9).

06.07.2022

"Regulation Amending the Regulation on Clinical Trials of Pharmaceuticals and Biological Products" was published.

12.08.2022

TITCK Department of Clinical Trials published the "Guideline on the Evaluation of Clinical Trials in Exceptional Situations".

24.09.2022

"Regulation Amending the Regulation on Clinical Trials of Pharmaceuticals and Biological Products" was published.

IMPORTANT MEETINGS & VISITS CONDUCTED AND REPORTS / OFFICIAL LETTERS SENT BY AIFD IN 2022 ON R&D & INNOVATION ISSUES

12.01.2022

An online meeting was held on Wednesday, January 12, 2022, with the participation of Dr. Sevil Azak Sungur, Deputy Head of Audit Services at MoH TITCK, and her team to discuss TITCK In-Clinic Phase I centers.

27.01.2022

A meeting was held with TÜSEB on January 27 with the participation of AIFD professionals and AIFD Clinical Trials management team on "Establishing clinical research centers with dedicated staff - Site Coordination".

14.02.2022

Our views on Article 3 (1), Article 4 (1), Article 5 (1), Article 9, Article 10 (1), Article 10 (2), Article 12 (6), Article 12 (12), Article 12 A (2), Article 12 A (3), Article 13 (3), Article 14, Article 20 (5) and Article 23 (1) of the Draft Regulation on Clinical Trials of Pharmaceuticals and Biological Products were shared with the TITCK Vice Presidency of Pharmaceuticals and Pharmacy.

21.02.2022

Meeting with Assoc. Dr. Emre Adıgüzel, Deputy Chief Physician Coordinator of Ankara City Hospital to evaluate current sector issues and problems.

24.02.2022

AIFD's opinion and suggestions regarding the "Directive on the Procedures and Principles Regarding the Studies to be Conducted with the Request of the Sponsor within the Scope of Revolving Fund Management" were conveyed to the Ministry of Health, General Directorate of Public Hospitals, Department of Health Care, Patient Services and Education. Our opinions on Article 6, Article 7, Article 9 (1) b, Article 9 (4) and Article 11 of the Directive on the payment of clinical trials in public hospitals through revolving funds were communicated.

09.03.2022

AIFD Chairman Dr. Mete Hüsemoğlu and Secretary General Dr. Ümit Dereli held a meeting with TITCK President Assoc. Dr. Tolga Karakan. During the meeting, the priority issues and problems on the agenda of our sector were conveyed and mutual evaluations were made for their solutions.

09.03.2022

AIFD opinions and suggestions regarding the 'Guideline on Phase I Clinical Research Centers' were communicated to the TITCK Vice Presidency of Audit Services. The relevant regulations in the current "Guideline on Phase I Clinical Research Centers" are prepared according to the requirements of phase I centers where Phase I research with healthy volunteers is conducted; in this respect, the request for the inclusion of amendments (such as the removal of some obligations or the creation of exceptional implementations) regarding clinical research with sick volunteers in the relevant articles in the said Guideline has been forwarded to the TITCK Vice Presidency of Audit Services.

13.04.2022

A meeting was held with Ankara City Hospital Coordinator Chief Physician Op. Dr. Aziz Ahmet Surel, on the specific issue of clinical research.

14.04.2022

"AIFD Chairman Dr. Mete Hüsemoğlu, AIFD Secretary General Dr. Ümit Dereli came together with the Deputy Minister of Health Assoc. Prof. Dr. Tolga Tolunay. During the meeting, the priority issues and problems on the agenda of our sector, especially the drug exchange rate problem, were conveyed in detailed manner and mutual evaluations were made for their solutions."

28.04.2022

AIFD Chairman Dr. Mete Hüsemoğlu and AIFD Secretary General Dr. Ümit Dereli met with TITCK President Assoc. Dr. Tolga Karakan. During the meeting, the planning framework for the workshop to be organized with the participation of AIFD & TITCK and Price Valuation Commission members was outlined.

09.05.2022

Mutual evaluations were made with Assoc. Prof. Dr. Mehmet Kürşat Derici, Vice President of Economic Evaluations and Laboratory Services at TITCK, regarding the planning of the AIFD Public Stakeholder meeting.

23.05.2022

A meeting on "The Importance of Intellectual Property Rights in the Pharmaceutical Industry" organized by the Thoracic Society (Toraks Derneği) was held and Secretary General Dr. Ümit Dereli attended the meeting on behalf of AIFD.

24.05.2022

A meeting was held with Assistant Chief Physician of Ankara City Hospital, Assoc. Prof. Emre Adıgüzel. During the meeting, mutual evaluations were made on the planning of the Clinical Research Workshop.

07.06.2022

The outcome of the Clinical Trials investment and approval survey was communicated in writing to TITCK.

15.06.2022

AIFD letter concerning the suggested countries with which MRA could be signed is forwarded to TITCK as part of Investment Environment Improvement Coordination Board Action Plan.

16.06.2022

AIFD participated in a meeting with Mr. Çetin Ali Dönmez, Deputy Minister of the Ministry of Industry and Technology, held with the participation of the Presidency Investment Office, AIFD and Clinical Research Association.

07.07.2022

During the visit to the office of Ambassador Mehmet Kemal Bozay, Permanent Representative of Türkiye to the EU, EU-Türkiye Health Dialogue, Türkiye-EU R&D Summit, Clinical Trials, update of the Customs Union were discussed.

08.08.2022

A meeting was held with the Turkish coordinators of the EU Commission's Directorate General for Trade (DG Trade) and EU-TR Health Dialogue, Customs Union update and other regulatory issues were discussed.

18.07.2022

AIFD & Cerrahpaşa Clinical Research Excellence Application and Research Center Meeting was conducted.

04.08.2022

"AIFD & Ankara City Hospital Clinical Trial Meeting” was conducted.

25.08.2022

AIFD letter concerning the signing of MRA between TR and UK is forwarded to TITCK and The Ministry of Commerce.

12.09.2022

On September 12, 2022, AIFD met with Assoc. Prof. Dr. Mehmet Kürşat Derici, Vice President of TITCK, and discussed the inclusion of hospital products in the real source price calculation within the scope of the First Interim List of the 2022 Price Change Period. AIFD opinions and suggestions were conveyed

27.09.2022

A meeting was held with Mr. Osman Nuri Erdem, Director General of Plans and Programs at the Presidential Strategy and Budget Directorate, regarding the preparations for the 12th Development Plan.

28.09.2022

A follow up letter concerning the issues brought to discussion during the Ankara City Hospital Clinical Trials Meeting was dispatched.

28.09.2022

A meeting was held with Mr. Uğur Gelir, Head of the Manufacturing Industry Department of the General Directorate of Sectors and Public Investments of the Presidential Strategy and Budget Directorate, regarding the preparations for the 12th Development Plan.

05.10.2022

Participation was made in the TOBB Pharmaceutical Sector Assembly; R&D, Production, Localization and Technology Sub-Committee Meeting.

12.10.2022

A meeting was held with Assoc. Prof. Dr. Mehmet Kürşat Derici, Vice President of TITCK. During the meeting, the issue of taking hospital products into account in the real source price calculation within the scope of the First Interim List of the 2022 Price Change Period was evaluated. AIFD views and suggestions were conveyed.

17.10.2022

On behalf of the AIFD Board of Directors, a delegation consisting of our Chairman Dr. Mete Hüsemoğlu and Board Members Cem Açık, Demet Russ, Şehram Zayer, Gözde Güllüoğlu, Özdemir Şengören and AIFD Secretary General Dr. Ümit Dereli held a meeting with TITCK President Dr. Asım Hocaoğlu. During the meeting, the consideration of hospital products in the real source price calculation, prioritization and other sectoral issues were discussed within the scope of the First Interim List of the 2022 Price Change Period.

20.10.2022

AIFD Secretary General Dr. Ümit Dereli participated as a panelist in the thematic session on "Conventional and Biotechnological Pharmaceutical Molecules Needed Primarily in Türkiye and Production Strategies" organized within the scope of the Symposium on API Technologies and Development Processes from Global to Türkiye.

26.10.2022

AIFD & Ege University Medical Faculty Clinical Trials Center Meeting was held.

03.11.2022

A meeting was held with Ms. Elif İnci Ergönül, Head of the Department of Clinical Research, with the participation of AIFD professionals and AIFD Clinical Trials Management Team, on the digitalization in clinical research.

03.11.2022

During the meeting held with Dr. Emre Orhan Öztelli, Director General for International Trade in Services at the Ministry of Trade, and Mr. Alperen Kaçar, Assistant Director General, the importance of the availability of innovative products in our country for our country to become an important destination in health tourism was emphasized and the results of EFPIA's WAIT Survey study were shared in this context.

10.11.2022

AIFD participated to TOBB R&D, Production, Localization and Technology Subcommittee Meeting.

28.11.2022

A meeting was held with Mr. Uğur Gelir, Head of the Manufacturing Industry Department of the General Directorate of Sectors and Public Investments of the Presidential Strategy and Budget Directorate, regarding the preparations for the 12th Development Plan.

28.12.2022

AIFD letter regarding invoice payments was sent to Cerrahpaşa Clinical Research Excellence Application and Research Center.

13.12.2022

AIFD participated in the Current Situation and Recommendations Workshop on Clinical Trials organized by TÜSEB in Ankara on December 13, 2022.

14.12.2022

AIFD participated in the 2nd Symposium on the Place of Academic Research Institution in the Clinical Research Ecosystem.

21.12.2022

An official letter was sent to the Ministry of Environment, Urbanization and Climate Change regarding the UN COP 27 outcomes.

22.12.2022

AIFD participation to the first meeting of Pharmaceuticals in Health System Working Group held in Ankara in the framework of 12th Development Plan.