AIFD ÇALIŞMA RAPORU

LICENSING POLICIES

Currently, the finalisation of TITCK license granting processes takes longer than the periods specified in the legislation. The number of files pending for evaluation at the Agency after their initial review is high, the waiting time in the slot was approximately 1 year in the first half of 2022; a positive development was observed however and waiting period decreased to approximately 6 months in the last half of the year.

The problems experienced by our members in the licensing processes and the proposed solutions to these problems were verbally conveyed to the Ministry of Health and TITCK officials in various meetings held at different levels throughout the year. Official letters were also prepared on sectoral problems and submitted to the TITCK in December 2021 and June 2022.

As in previous years, AIFD conducted a survey in 2021 to obtain data on the Licensing and Good Audit Practices (GMP) processes and to assess the situation. Within the scope of the survey, data for the period 01.06.2020-31.12.2021 were collected and the survey results were shared with our members in 2022. The main survey data are given below.

License File Application Status

Out of 189 products compiled by AIFD members in the survey, 56 products were granted license while 133 products were still in the licensing process during the period covered by the survey.

Data on license status and evaluation periods by product category are presented below.

Chart 1: Licensing per product categories as per 31.12.2021

Chart 2: Time periods between license application and license approval dates

Calculated as the time between the date of marketing authorization application and the date of marketing authorization approval, the average time for the completion of marketing authorization was 695 days for high priority products, 949 days for priority products and 1176 days for non-priority products.

Chart 3: Timeline between the start date of the review and the license approval date for 210/180/150 days schedule

When the 210/180/150 days between the start date of the review and the date of marketing authorization approval processes are evaluated, it is seen that the average time to complete the marketing authorization process is 581 days for high priority products, 847 days for priority products and 1017 days for non-priority products.

Chart 4: Comparison between the start date of the review and the license approval date with previous survey periods for the of 210/180/150 days schedule

In the 2021 survey period, it is observed that the 210/180/150 days Schedule between the start date of the review and the license approval date has significantly extended compared to previous years.

2022 Number of License Approvals

Data on newly licensed products were analyzed based on the lists published weekly by TITCK and shared monthly with the committee members. Details on the number of applications approved by TITCK in 2022 as of 20.01.2023 are presented in Chart 5. A total of 608 new licenses were issued in 2022. There was an increase in 2022 compared to 2020 and 2021 in issuing new licenses.

Chart 5: Number of New Licenses in 2022

Prioritization Process

Article 15 of the "Regulation on the Marketing Authorization of Medicinal Products for Human Use", which is the basis for the authorization of medicinal products for human use to be placed on the Turkish market, states that the authorization procedures of the applications deemed appropriate by the Priority Evaluation Board will be evaluated with priority and will be completed within the periods specified in the Guidelines on Prioritization published by the Agency.

Prioritized/accelerated marketing authorization processes are implemented by different authorities around the world, and the implementation in our country is carried out according to the "Guideline on the Working Procedures and Principles of the Priority Evaluation Board for Medicinal Products for Human Use" published on 13.04.2016.

The prioritization process was operated effectively in the first years of the Guideline's publication, with the Board meeting regularly on a monthly schedule and the process being carried out without interruption. In 2022, the Priority Assessment Board convened only when deemed necessary instead of holding regular meetings, and these meetings did not take into consideration the marketing authorization and GMP prioritization applications of products that apply for marketing authorization, resulting in significant disruptions in the marketing authorization process of innovative medicinal products.

For the period 01.06.2020-31.12.2021, the average application evaluation period for the priority evaluation process was 119 days. This period was 93 days for high priority products, 116 days for priority products and 154 days for non-prioritized products. In the survey period 01.01.2017-31.12.2018, in which prioritization application evaluation processes were measured, the general average was 69 days. Data on the survey results for both periods are presented in Chart 6.

Chart 6: Comparison of Prioritization Assessment Times

In addition to the aforementioned survey data, cross-sectional surveys on the prioritization process were conducted in April and September 2022 with the contributions of AIFD member companies. According to the data obtained from these surveys, while the number of applications of our member companies waiting in the prioritization process was 50 in April, this number increased to 113 in September. As of September, 35 products have been waiting for priority assessment for 6-9 months, 28 products for 9-12 months and 6 products for more than 15 months. These waiting periods increased by 3 months as of December, and for most of the pending applications, this period has exceeded 12 months.

Data on the survey results are presented in charts 7 and 8. Chart 7: Cross-Sectional Survey on Prioritization Assessment - September 2022

Chart 8: Prioritization Assessment; April and September 2022; Cross-Sectional Surveys

In 2022, the disruptions in the prioritization processes delayed both the start of GMP audit processes and the licensing processes of innovative products, which, as defined in the guideline, aim to improve health and quality of life and are the first in diagnosing and treating diseases faster, more effectively or at lower costs. Due to the importance of the issue, the problems experienced in the prioritization processes were raised in detail in the meetings held at different levels in 2022, and the issue was conveyed to the Deputy Minister of Health, the President of TITCK and the Head of the Department. The issue of prioritization was also discussed in detail at the AIFD-Public Pharmaceutical Sector Workshop held on May 26, 2022. Furthermore, our problems and expectations regarding the processes were shared with the TITCK in writing.

As an important development, as of the end of December 2022, the products for which prioritization applications were submitted started to be discussed by the Priority Evaluation Board. As of the end of 2022, revised guideline on prioritization has not yet been published.

Analysis for Licensing Purposes

One of the important issues in achieving the goal of "Timely Access to Innovative Products" is the improvement of the analysis process at the licensing stage. Although the analysis process is carried out in parallel with other review and evaluation processes related to licensing, the long duration of the analysis process and various problems in the process may cause delays in license approvals.

Considering both the importance of market surveillance and the delay in licensing processes due to analysis, it has been requested that the necessary amendments to the law and regulations be made in order to carry out the analyses as a separate process within the framework of market controls without hindering the issuance of licenses. Until these amendments are made, work continues within the Health Sciences Policies SMC on the disruptions experienced in the Analysis for Licensing processes.

The Analysis Processes Working Group, consisting of volunteer members of our Strategic Management Committee, came together in various meetings in 2022 and identified the problems and solution suggestions. During the meeting with Assoc. Prof. Dr. Mehmet Kürşat Derici, Vice President of TITCK Economic Assessments and Laboratory Services, and Ms. Emine Lale Demirel, Head of Analysis and Control Laboratories Dept., AIFD made a presentation on the relevant problems and solution proposals and mutual evaluations were made.

Legislation Issued during 2022

The list of legislations published by the TITCK in 2022 within the scope of Health Science Policy activities is presented below:

PUBLICATION DATE	ISSUING TITCK DEPARTMENT	LEGISLATION - PUBLICATION
18/01/2022	Pharmaceutical Licensing Dept.	Application Form and CTD Guide revision within the scope of the Regulation on the Licensing of Medicinal Products for Human Use published on 11.12.2021 + Announcement about Hybrid and Diversification applications
20/01/2022	Pharmaceutical Licensing Dept	Guidance on Variations in Licensed Medicinal Products for Human Use Notification/Application Form For Variations in Licensed Medicinal Products for Human Use
26/01/2022	Dept. Herbal and Dietary Supplement Products	Draft Regulation on Permission for Special Medical Nutritional Products
11/02/2022	Pharmaceutical Inspection Dept	Guideline on Serial Release
15/02/2022	Pharmaceutical Inspection Dept	Guideline on the Inspections of Good Distribution Practices
25/02/2022	Pharmaceutical Inspection Dept	* Guidance on Triggers for Audits of Bioavailability/Bioequivalence Studies * Guidance on Triggers for Routine and/or "For a Specific Reason" Inspections
08/03/2022	Pharmaceutical Inspection Dept	Application Guide for Good Clinical Practice Audits
08/03/2022	Herbal and Dietary Supplement Products Dept	Draft Regulation on the Use of Health Declarations
09/03/2022	Pharmaceutical Licensing Dept	Guidance on the Licensing of Allergenic Products
12/03/2022	Pharmaceutical Inspection Dept	Additional Measures to be Implemented During the Pandemic Regarding GMP Audits and Certification Processes Abroad
15/03/2022	Herbal and Dietary Supplement Products Dept	Guidance on License Application for Homeopathic Medicinal Products * Guideline on Packaging and Homeopathic Medicinal Product Information, Readability and Monitoring of Homeopathic Medicinal Products
15/03/2022	Strategy Development Department	Turkish Medicines and Medical Devices Agency Communication Cooperation and Information Sharing Guideline
14/04/2022	Pharmaceutical Licensing Dept	Guidance on the Classification of Diversification Applications and Variation Applications
22/04/2022	Pharmaceutical Inspection Dept	Good Manufacturing Practices (GMP) Guidance for Manufacturers of Medicinal Products for Human Use
22/04/2022	Pharmaceutical Inspection Dept	Guidance on Communication, Organization and Responsibilities of Stakeholders in Market Monitoring Programs
27/04/2022	Dept. of Pharmacovigilance and Controlled Substances	Crisis Management Guide in Pharmacovigilance Activities
27/04/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guidelines Module IX Annex I - Training Materials
27/04/2022	Dept. of Pharmacovigilance and Controlled Substances	Guide to Good Pharmacovigilance Practices (IFU) Module IX - Risk Minimization Measures: Selection of Tools and Efficacy Indicators
27/04/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guidelines Module VIII - Safety Communication
28/04/2022	Pharmaceutical Licensing Dept	Guideline on Investigation of Bioavailability and Bioequivalence of Medicinal Products for Human Use
11/05/2022	Strategy Development Department	Guideline on Good Regulatory Implementation Practice
07/06/2022	Herbal and Dietary Supplement Products Dept	New Health Declaration Application Draft Guideline
07/06/2022	Herbal and Dietary Supplement Products Dept	Draft Guideline on Packaging Information and Readability of Foods for Special Medical Purposes
10/06/2022	Pharmaceutical Inspection Dept	Regulation Amending the Regulation on Manufacturers of Medicinal Products for Human Use
16/06/2022	Pharmaceutical Inspection Dept	Announcement on "GMP Processes Required for the Authorization of Allergenic Products"
20/06/2022	Herbal and Dietary Supplement Products Dept	* Draft Guidance on the Use of Health Claims * Annex to the Draft Guideline on the Use of Health Declarations
20/06/2022	Dept. Herbal and Dietary Supplement Products	Announcement on “Traditional Herbal Medical Medical Products containing "Hedara Helix L.”
20/06/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guideline Module X - Pre-marketing Benefit/Risk Assessment
20/06/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guideline Module XI - Post-marketing Benefit/Risk Assessment
07/07/2022	Dept. Of Analysis and Control Laboratories	Revision of Sample Acceptance Criteria Procedure
03/08/2022	Pharmaceutical Licensing Dept	Announcement regarding the "Regulation in the Affairs and Procedures of the Department of Drug Licensing due to the COVID-19 Pandemic" (Accordingly, the announcement dated August 26 is no longer valid)
03/08/2022	Dept. of Pharmacovigilance and Controlled Substances	Guide to Good Pharmacovigilance Practices Annex I - Definitions (1st revised edition)
09/08/2022	Pharmaceutical Inspection Dept	Guidance on Risk-Based Good Clinical Practice Audits
09/08/2022	Pharmaceutical Inspection Dept	Reliance Guideline for Good Manufacturing Practice Assessments
11/08/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guidelines Module VI - Risk Management Systems (Corrected 1st edition)
11/08/2022	Dept. Of Analysis and Control Laboratories	Guidance on Serial Release of Vaccines and Immune Serums
12/08/2022	Pharmaceutical Inspection Dept	Guidance on Good Distribution Practices (GDP) for Medicinal Products for Human Use
25/08/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guideline Module III -Periodic Benefit/Risk Assessment Report
25/08/2022	Dept. of Pharmacovigilance and Controlled Substances	Pharmacovigilance Indicators Guide
26/08/2022	Pharmaceutical Licensing Dept	Announcement on "Prioritization request applications for supply issues of variation applications for licensed Medicinal Products for Human Use"
29/08/2022	Dept. Of Rational Drug Use	Guidance on Donations of Human Medicinal Products from Abroad that are not licensed in Türkiye
02/09/2022	Dept of Clinical Research	Guidance on Reliance Practices in Clinical Trial Applications
02/09/2022	Dept. of Pharmacovigilance and Controlled Substances	Draft Guideline on Reliance Practices in Pharmacovigilance Activities (The final Guideline was published on 09.09.2022)
02/09/2022	Pharmaceutical Licensing Dept	Information on Nitrosamines
05/09/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (IFU) Guide Module VII - Signal Management (Revised 1st edition)
07/09/2022	Strategy Development Department	Guidance on the Management of Crises and Emergencies Where Routine Regulatory Processes for Medicinal Products for Human Use cannot be Followed
09/09/2022	Dept. of Pharmacovigilance and Controlled Substances	Guidance on Reliance Practices in Pharmacovigilance Activities
12/09/2022	Pharmaceutical Inspection Dept	Internal Communication Guideline of the Medicines Inspection Department (revised guideline published on 24.09.2022)
15/09/2022	Pharmaceutical Licensing Dept	Guidelines on Principles and Processes of Good Evaluation Practices in the Licensing and Post-licensing Procedures of Medicinal Products for Human Use
20/09/2022	Pharmaceutical Inspection Dept	Guidance on Applications for GMP Audits of Overseas Production Facilities
20/09/2022	Pharmaceutical Inspection Dept	Guidance on Centers where Bioavailability and Bioequivalence Studies are conducted
24/09/2022	Pharmaceutical Inspection Dept	Application Guide for Places Assessed under Good Distribution Practices (GDP)
24/09/2022	Pharmaceutical Inspection Dept	Application Guide for Medicinal Product Facilities for Human Use
24/09/2022	Pharmaceutical Inspection Dept	Medicines Inspection Department Internal Communication Guide (Revision.01)
25/09/2022	Pharmaceutical Licensing Dept	Regulation Amending the Regulation on Licensing of Medicinal Products for Human Use
26/09/2022	Pharmaceutical Licensing Dept	Guidance on Reliance Practices Regarding the Authorization Process of Medicinal Products for Human Use
30/09/2022	Pharmaceutical Inspection Dept	Regulation on Serial Release of Vaccines and Immune Serums
12/10/2022	Pharmaceutical Licensing Dept	Announcement on Variation Applications Submitted within the Scope of Reliance for Licensed Medicinal Products for Human Use
13/10/2022	Pharmaceutical Inspection Dept	Regulation on Serial Release of Vaccines and Immune Serums
07/11/2022	Pharmaceutical Licensing Dept	Frequently Asked Questions & Application Considerations Documents have been announced
16/11/2022	Dept. of Pharmacovigilance and Controlled Substances	Draft Guideline on Pharmacovigilance System (Final Guideline published on 05.12.2022)
30/11/2022	Dept of Analysis ans Control Laboratories	Regulation on the Duties, Authorities and Responsibilities and Working Procedures and Principles of the National Control Laboratory of the Turkish Medicines and Medical Devices Agency
05/12/2022	Dept. of Pharmacovigilance and Controlled Substances	Pharmacovigilance System Guideline (entered into force on 30.11.2022)
05/12/2022	Dept. of Pharmacovigilance and Controlled Substances	Good Pharmacovigilance Practices (GPP) Guideline Module XI - Postmarketing Benefit/Risk Assessment Revision
12/12/2022	Pharmaceutical Inspection Dept	Pharmacovigilance Audit Guide
12/12/2022	Pharmaceutical Inspection Dept	* Revision of Guideline on Good Distribution Practices Audits * Revision of Guideline on Good Distribution Practices for Medicinal Products for Human Use (GDP) * Revision of Application Guideline for Places Assessed under Good Distribution Practices (GDP)
13/12/2022	Pharmaceutical Inspection Dept	Guideline for Communication with External Stakeholders of the Vice Presidency of Audit Services
15/12/2022	Pharmaceutical Inspection Dept	Revision of the Guideline on Human Medicinal Product Facilities Risk Assessment Application
15/12/2022	Dept. of Economic Assessments and Pharmaceutical Supply Management	Announcement on the Cancellation of the Decision on the Extension of the Approval Periods for the Use of Off-label/International Medicinal Products
15/12/2022	Pharmaceutical Inspection Dept	Revision of the Guideline on Serial Release Location Application
15/12/2022	Pharmaceutical Inspection Dept	Revision of the Guideline on Production Location Permit Renewal Application
15/12/2022	Assessments and Pharmaceutical Supply Management	Announcement to update the List of Off-label Medicinal Products that can be used without obtaining TITCK's Additional Approval
16/12/2022	Pharmaceutical Licensing Dept	Regulation Amending the Regulation on Licensing of Medicinal Products for Human Use
21/12/2022	Pharmaceutical Inspection Dept	Revision of Guideline for Application for Medicinal Product Facilities for Human Use
23/12/2022	Pharmaceutical Licensing Dept	Announcement on Pharmaceutical Licensing Agency Company Meetings
30/12/2022	Pharmaceutical Inspection Dept	Guidance on Applications for GMP Audits of Production Facilities in other countries

In addition to the aforementioned legislation published by TITCK, "Rare Diseases Health Strategy Document and Action Plan" was published on 23/11/2022 by the Directorate General of Health Services, Department of Autism Mental Special Needs and Rare Diseases.

MAJOR ACTIVITIES

Contacts with Stakeholders

In 2022, meetings were held online and face-to-face within the scope of the issues falling within the fields of activity of the Health Science Policies SMC, and the problems and solution proposals identified by AIFD member companies were shared and the process was effectively monitored.

DATE	RELATED INSTITUTION (S)	CONTACT PERSON(S)	SUBJECT
16/02/2022	TITCK Dept. of Analysis and Control Laboratories	Doç. Dr. Mehmet Kürşat Derici	Areas where cooperation with AIFD could be contemplated were evaluated.
25/02/2022	GHI (GSS) Medicines Dept	Dr. Tuncay Alkan	Current issues related to Rare Diseases were evaluated.
02/03/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy	Dr. Asım Hocaoğlu	The revision of the Prioritization Guideline and TITCK participation to DIA 2022 were discussed.
03/03/2022	TITCK Dept. of Pharmaceutical Licensing	Uzm. Ecz. Handan Öztunca	Evaluations were made on the revision of the Prioritization Guideline, problems encountered in the scope of Summary Product Information (SmPC) and Instructions for Use (KT) applications and also on DIA 2022 Organization.
23/03/2022	TITCK Dept. of Pharmaceutical Licensing	Uzm. Ecz. Handan Öztunca	Evaluations were made on current issues/problems within the scope of licensing processes.
07/04/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy, TITCK Dept. of Pharmaceutical Licensing	Dr. Asım Hocaoğlu, Uzm. Ecz. Handan Öztunca	The presentation prepared by the AIFD Reliance working group on Reliance Practices was presented and mutually evaluated.
14/04/2022	Vice Director of Health Services	Doç. Dr. Mehmet Gündüz	Rare Diseases report prepared by AIFD&IQVIA was evaluated.
26/05/2022	TITCK & GHI (GSS)	Governmental Workshop	Mutual evaluations were made on Prioritization Processes, Pricing and Exchange Rate Policies, Parallel Export issues.
22/06/2022	TITCK Vice Presidency of Audit Services	Dr. Ecz. Sevil Azak Sungur	Evaluations were made within the scope of on-site inspection plans, Reliance Implementation in the Regulation on Manufacturers of Medicinal Products for Human Use, and GMP Prioritization..
29/06/2022	TİSD, İEİS	Dernek ve Sendika temsilcileri	Evaluations were made within the scope of the Good Distribution Practices Guidelines.
01/07/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy, TITCK Department of Pharmaceutical Licensing	Dr. Asım Hocaoğlu, Uzm. Ecz. Handan Öztunca	Evaluations were made within the scope of our Sector Problems Letter sent to TITCK.
03/08/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy	Dr. Asım Hocaoğlu	Evaluations were made on prioritization, licensing processes, expected legislation, e-CTD and communication.
21/09/2022	TITCK Department of Pharmaceutical Licensing	Uzm. Ecz. Handan Öztunca	Evaluations were made on current issues such as e-CTD transition plan, prioritization processes, Reliance practices approach, Frequently Asked Questions document, appointments with TITCK departments.
17/10/2022	TITCK Presidency	Dr. Asım Hocaoğlu	Assessments were made on the prioritization process and other sectoral issues.
17/10/2022	Vice Presidency of Ministry of Health	Doç. Dr. Tolga Tolunay	Assessments were made on the prioritization process and other sectoral issues.
08/11/2022	TITCK Presidency, TITCK Dept. of Pharmaceutical Licensing	Dr. Asım Hocaoğlu, Uzm. Ecz. Handan Öztunca	Evaluations were made on the Prioritization Guidelines, the current situation regarding the elimination of analysis processes for licensing purposes, WHO Audit process, TITCK & AIFD Consultation Meeting, participation to DIA 2023
08/11/2022	TITCK Vice Presidency of Audit Services TITCK Vice Presidency of Pharmaceuticals and Pharmacy	Dr. Ecz. Sevil Azak Sungur, Kim. Müh Filiz Ozul	Assessments were made on Mutual Recognition Agreements (MRAs), MRAs that TITCK can conclude with PIC/s Member Countries, On-Site Inspection Plans and Certificate Periods, TITCK & AIFD Consultative Meeting, List of inspected facilities, Reliance Guideline for Good Manufacturing Practice Assessments.
21/11/2022	TITCK Dept. of Pharmaceutical Licensing	Uzm. Ecz. Handan Öztunca	Evaluations were made on the Licensing Regulation and current issues.

Submitted Official Letters

DATE	INSTITUTION	SUBJECT
28/01/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy	Information and country examples within the scope of reliance in regulatory and supervisory activities
31/01/2021	TITCK Licensing Coordination Unit	Frequently Asked Questions document complied from questions of AIFD members
08/02/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy	AIFD agenda items for TITCK Consultancy Meeting
14/03/2022	TITCK Vice Presidency of Pharmaceuticals and Pharmacy	AIFD input for the Draft Good Distribution Practices Guidelines
29/03/2022	TITCK Information Systems Department	ITS database (Pharmaceutical Track and Trace System) change time extension request (joint letter of 4 associations)
08/04/2022	TITCK Herbal and Dietary Supplement Products Dept	AIFD comments on the Draft Regulation on the Use of Health Claims
19/04/2022	TITCK Deputy Head of Drug Inspection Dept.	AIFD comments on the Draft Regulation on Pharmaceutical Traders and Products Stored in Pharmaceutical Traders
14/06/2022	TITCK Dept. of Pharmaceutical Licensing	AIFD Questions under the Diversification Guidance
15/06/2022	TITCK Dept. of Pharmaceutical Licensing	Joint letter of associations on sector issues
15/06/2022	General Directorate of Health Services, (SHGM) Dept. of Autism, Mental Special Needs and Rare Diseases	AIFD Comments on the Draft Document on Rare Diseases Health Strategy
07/07/2022	TITCK Dept. of Pharmaceutical Licensing	Extension of Nitrozamin timeline (joint letter of 4 industry associations)
18/07/2022	TITCK Deputy Head of Drug Inspection Dept.	AIFD views for Guidance on Applications for GMP Audits of Overseas Production Facilities
02/08/2022	TITCK Deputy Head of Drug Inspection Dept.	Frequently Asked Questions compiled from AIFD member companies
22/11/2022	TITCK Dept. of Pharmaceutical Licensing	Problems experienced by AIFD member companies within the scope of Variation Application, Evaluation and related EBS (electronic application) processes, and suggestions for solutions to these problems
02/12/2022	TITCK Deputy Head of Drug Inspection Dept.	AIFD views for the revised Guidance on Applications for GMP Audits of Overseas Production Facilities
16/12/2022	General Directorate of Health Services, (SHGM) Dept. of Autism, Mental Special Needs and Rare Diseases	About the workshop to be held within the scope of Rare Diseases Health Strategy Document and Action Plan

Meeting/Symposium/Congress Participations

During 2022, the Meetings/Symposiums/Congresses attended online or physically by AIFD professionals are presented below:

DATE	NAME OF THE MEETING/SYMPOSIUM/CONGRESS
20/01/2022	İstinye Uni. Pharmacy Faculty external stakeholders meeting
15/02/2022	TITCK Sector Consultative Meeting
23/02/2022	IPTS (International Pharmaceutical Technology Symposium) 2022
28/02/2022	Health Services General Directorate Rare Diseases Awareness Day Symposium
24/02/2022	Hacettepe Uni. Pharmacy Faculty external stakeholders meeting
10/03/2022	8th Hospital and Institution Pharmacists Congress
28/03-01/04/2022	Drug Information Association (DIA) EUROPE Meeting
28/05/2022	Metabolic Diseases and Nutrition Congress
02/06/2022	TÜSEB Future Health Technologies Summit
20-21/10/2022	Bioexpo 2022
15/12/2022	(WHO 10th Annual Meeting on Collaborative Registration Procedure)
16/12/2022	6th Health Economics Congress Health Economics and Policies Association (SEPD )
22/12/2022	Rare Diseases Future, Centers of Excellence Symposium

AIFD actively participated in the Licensing and Biosimilar Subcommittees of the Pharmaceutical Industry Council of the Union of Chambers and Commodity Exchanges of Turkey (TOBB). With the cooperation of participants from associations, trade unions and companies representing the sector in these committees, content was prepared in the meetings shown in the list below, to be shared with TITCK within the scope of the evaluations made on the legislation as well as the needs of the sector. Presentations on the relevant content were made at the Turkish Pharmaceutical Industry Council held on December 26, 2022.

DATE	MEETING
18/10/2022	TOBB Pharmaceutical Sector Council Licensing Sub-Committee Meeting
25/10/2022	TOBB Pharmaceutical Sector Council Biosimilars Subcommittee Meeting
08/11/2022	TOBB Pharmaceutical Sector Council Licensing Sub-Committee Meeting
15/11/2022	TOBB Pharmaceutical Sector Council Licensing Sub-Committee Meeting
22/11/2022	TOBB Pharmaceutical Sector Council Biosimilars Subcommittee Meeting

TABLE OF CONTENTS