Recent developments in healthcare legislation - Issue 2026/1

Medicinal products for human use

Amendment to the guideline on trust practices in clinical trial applications. The Guideline on Trust Practices in Clinical Trial Applications published by the Turkish Medicines and Medical Devices Agency (“Agency”) was updated on 14 November 2025. Within this scope, among other changes, the following were introduced: (i) the requirement of OECD membership for Good Laboratory Practices (GLP) certification has been abolished; (ii) it has been made mandatory that the apostille annotation for documents in the investigational product dossier be obtained from the country where the documents were issued, (iii) the requirements relating to Good Manufacturing Practices (GMP) certificates have been differentiated for chemical and biological active substances, and four alternative certification pathways have been introduced for non-authorised products; and (iv) the Agency’s powers to conduct inspections at manufacturing facilities and to suspend research have been expressly regulated.

Amendment to the guideline on applications for clinical trial investigator meetings. The Guideline on Applications for Clinical Trial Investigator Meetings was updated on 1 December 2025, introducing changes to the application procedures and principles for investigator meetings in clinical trials. Accordingly, it is now mandatory to submit applications at least 22 business days in advance for in-person meetings and 15 business days in advance for online meetings. In addition, social events such as dinners and cocktails, which were previously subject to approval, are no longer permitted to be included in the meeting programme.

Amendment to the regulation on the licensing of medicinal products for human use. The amendments to the Regulation on the Licensing of Medicinal Products for Human Use were published on 30 December 2025, extending certain transition periods. In this context:

• Radiopharmaceutical products: The transition period for completing the licensing process for radiopharmaceutical products that are marketed under a certificate of registry and for which a marketing authorisation application has been submitted has been extended from 31 December 2025 to 1 January 2027. If a marketing authorisation is not obtained within this period, the relevant certificate of registry will become invalid.
• Allergen products: The transition period for placing on the Turkish market the allergen products that they are manufactured and already marketed in European Union (“EU”) under certain conditions has been extended from 1 January 2026 to 1 January 2027.
• Clinical trials conducted abroad: Where clinical trials forming the basis of a marketing authorisation application are conducted outside Türkiye, the obligation to submit certain documents to the Agency has been postponed until 1 January 2027. Accordingly, until this date, the following will not be required: (i) a clinical trial authorisation for trials approved by the TGA, MHRA, or competent authorities that are founding or permanent members of the ICH; and (ii) a Good Clinical Practices (GCP) compliance inspection report for trials approved by other relevant authorities.

Amendment to the principles on standard operating procedure of ethics committees for clinical trials and bioavailability/bioequivalence studies. Following the amendment dated 23 January 2026, the conditions and obligations governing the appointment of Ethics Committee members have been redefined. In this context, the appointment procedure to be followed in the event of termination of a substitute member’s mandate has been differentiated based on the member’s status, the existing structure of substitute members, and the minimum quorum requirements. New appointments must be submitted to the Agency for approval within 22 business days.

Clinical application guideline. The Clinical Application Guideline, which entered into force on 23 January 2026, sets out the procedures and principles for clinical applications to be carried out in Türkiye using domestically manufactured advanced therapy medicinal products, with the aim of ensuring access to regenerative medicine applications. The key provisions of the guideline are as follows:

• Scope: Tissue and cell products as well as advanced therapy medicinal products are excluded from the scope of clinical trials.
• Conditions for application: Clinical applications may be carried out subject to the approval of the Agency, where there is a medical need, the product cannot be developed on an industrial/commercial basis, no authorised product is available in Türkiye for the relevant indication, or existing treatment options fail to provide adequate results.
• Authorisation and implementation: Clinical application authorisations are granted on a patient-specific basis and does not constitute a precedent for other patients. Such applications may only be carried out by physicians who hold a clinical application certificate in the relevant specialty and are responsible for the treatment of the patient.

Amendment to the guideline on variations to authorised medicinal products for human use. The Agency updated the Guideline on Variations to Authorised Medicinal Products for Human Use on 19 March 2026, with the amendments set to enter into force on 15 April 2026. With this update, the classification criteria and procedures for variations have been aligned with international standards. In this context, the application of the reliance principle has been expanded. The annual update procedures applicable to vaccines have been enhanced through the introduction of specific provisions. In addition, new variation categories have been introduced for both active substances and finished products.

Decision on the pricing of medicinal products for human use. The decision, which entered into force on 12 March 2026, introduced comprehensive changes to the pharmaceutical pricing system and repealed the previous decision dated 2017.

Within this scope:

• Key concepts and pricing structure: The definition of the actual reference price has been revised as the “ex-factory price”; the concepts of “reference source price” and “company selling price” have been incorporated into the legislation.
• Euro adjustment and thresholds: The Euro conversion coefficient has been reduced from 70% to 65%, with different rates and values to be applied during the transitional period. In addition, price increases will now be based on the previous period’s Euro value rather than the “previous year”.
• Pricing regime and scope: Low-priced medicinal products and non-reimbursed products have been brought within the scope of exceptional pricing. The term “”foods for special medical purposes” has been introduced into the legislation, and products subject to value-based pricing have been incorporated into the system.
• Generic products and reference pricing: For generic products above certain thresholds, a phased pricing mechanism has been introduced for the first three years (80% – 75% – 70%). This system will apply only to the first generic products placed on the market following this new decision.
• Institutional structure and calculation principles: The structure of the pricing commission has been simplified; it is provided that profit margins will be calculated on the basis of the company selling price, and the scope of alternative reimbursement models has been expanded.

Amendments to the guidelines on packaging information and product information leaflets for medicinal products for human use. The Agency updated the Guideline on Packaging Information and Product Information Leaflets for Medicinal Products for Human Use on 27 February 2026 and 23 March 2026. Within this scope, except for products used exclusively by healthcare professionals, products with small packaging, and products without outer packaging, it has been made mandatory to provide access to Electronic Product Information Leaflet (e-PIL) on the packaging of medicinal products for human use. The inclusion of a printed patient leaflet has been made optional.

Regulation on cannabis cultivation and control, and regulation on products derived from cannabis. Under the Regulation on Cannabis Cultivation and Control, dated 31 January 2026, the provinces and districts where cannabis cultivation is permitted have been designated based on the purpose of production. The regulation also sets out the application procedures for cultivation permits, the eligibility criteria for cultivators, and the grounds for revocation of such permits. Under the Regulation on Products Derived from Cannabis, dated 31 January 2026, it has been made mandatory to obtain a marketing authorisation from the Agency for health and support products containing cannabis-derived components prior to being placed on the market. The Regulation further governs the qualifications required of applicants, the licensing process, and the principles relating to the suspension, revocation and transfer of licences. More detailed information regarding the amendments can be accessed from our announcement published on 6 February 2026: https://paksoy.av.tr/en/2026/02/legal-developments-regarding-the-cultivation-of-cannabis-and-cannabis-products/

Medical devices

Commission decision (EU) 2025/2371 on the functionality of EUDAMED electronic systems. On 26 November 2025, the European Commission confirmed, under its decision numbered (EU) 2025/2371, that certain electronic systems within the European Medical Devices Database (“EUDAMED”) are functional and meet the required functional specifications. Accordingly, the six-month transition period stipulated under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, which have been prepared in parallel with the EU Regulations, has commenced. Under the medical device regulations, the mandatory use of the relevant electronic systems in respect of the registration of economic operators, the UDI database and registration of devices, notified body and certificate notifications, and market surveillance obligations will become effective as of 28 May 2026.

Commission proposal for a targeted revision of the medical device regulations. On 16 December 2025, the European Commission published a legislative proposal aimed at simplifying, digitalising, and enhancing the rules on medical devices and in vitro diagnostic medical devices. The proposal, which prioritises competition, innovation, and patient safety, envisages, among others, the electronic submission of various documents and notifications such as declarations of conformity, and the removal of the maximum five-year validity period for notified body certificates, to be replaced by periodic review mechanisms proportionate to device risk. Should the proposal be adopted, it is expected that similar amendments will be introduced into the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, which have been prepared within the framework of harmonisation with the EU legislation.

Amendment to the regulation on technical service for medical devices used in the provision of healthcare services. With the amendment dated 30 December 2025, the compliance deadline for technical service activities relating to medical devices to meet the requirements under the regulation has been extended until 1 July 2027. Accordingly, the transition period for compliance with technical service obligations has been postponed by one and a half year, granting healthcare institutions and technical service providers additional time to align with the mandatory standards.

Announcement on products not assessed under the medical device regulations. Under the announcement published by the Agency on 8 January 2026, it has been reiterated that products not intended by their manufacturer for medical purposes cannot be classified under medical device legislation and, therefore should not be registered in the Product Tracking System (ÜTS). In addition, a list of sample products that fall outside the scope of the medical device regulations has been shared. This list serves as a practical reference for manufacturers and importers in relation to the classification of products.

Healthcare services

Regulation on promotion and information activities in healthcare services. The regulation dated 12 November 2025 repealed the regulation of the same name dated 29 July 2023, and regulates the principles, supervision, and sanctions regarding promotion and information activities in healthcare services. With the aim of protecting patient safety, patient rights, and public health, certain matters have been clarified, and new standards have been introduced for healthcare institutions and healthcare professionals (physicians, dentists, pharmacists, nurses, etc.). More detailed information regarding the amendments can be accessed from our announcement published on 13 November 2025: https://paksoy.av.tr/en/2025/11/recent-developments-in-healthcare-services/

Regulation on obesity units and obesity surgery implementation units. The regulation dated 12 November 2025 regulates the planning and classification of healthcare services related to obesity treatment and surgery, as well as the requirements of healthcare institutions providing such services, including physical conditions, minimum equipment, personnel, and equipment standards. More detailed information regarding the amendments can be accessed from our announcement published on 13 November 2025: https://paksoy.av.tr/en/2025/11/recent-developments-in-healthcare-services/

Regulation on radiation oncology services. The regulation, which entered into force on 16 December 2025, reregulates the procedures and principles governing radiation oncology clinical services and repeals the previous regulation dated 25 April 2023. In this context:

• Establishment and authorisation processes: It has been stipulated that centres may only be established within hospitals. A preliminary permit must be obtained from the Ministry of Health (“Ministry”) prior to the establishment of a centre or procurement of new equipment. Such preliminary permits will be revoked if not converted into a license within two years.
• Licensing and organisation: Cases such as relocation, merger, and transfer have been included within the scope of license/permit renewal. The centre director is required to work on a full-time basis and may also work at another centre within the same province (without holding the title of centre director).
• Transitional provisions: Existing centres may continue their operations; however, centres that do not meet the prescribed conditions will not be permitted to procure additional equipment.

Amendment to the regulation on radiology services. With the amendment dated 16 December 2025, significant changes regarding the establishment of centres, working regime, and sanctions applicable to radiology centres have been made in the Regulation on Radiology Services. In this context:

• Establishment and authorisation processes: The requirement to obtain Ministry authorisation for the addition of units, spatial changes, and relocations has been maintained. In addition, it has been expressly regulated that centres established by freelance radiologists may only be relocated within the same province.
• Licensing and organisation: A full-time working requirement has been introduced for radiology specialists serving as centre directors. Such specialists may work at only one additional centre within the same province (without holding the title of centre director). Radiology specialists who are not centre directors may work at a maximum of two centres within the same province. Compliance with the new working regime must be ensured by 1 June 2026.
• Sanctions: Sanctions have been tightened for centres that continue operating despite a suspension decision. In cases of continued non-compliance, the licence/operating permit shall be revoked.
• Transitional provisions: Existing centres may continue their operations; however, centres that do not meet the prescribed conditions will not be permitted to add new units.

Amendment to the regulation on nuclear medicine services. With the amendments dated 16 December 2025, significant changes regarding licensing, organisation, and operational principles have been introduced in the Regulation on Nuclear Medicine Services. In this context:

• Establishment and authorisation processes: The procedures for licensing and authorisation processes as well as structural changes (relocation, transfer, merger, etc.) have been clarified.
• Licensing and organisation: New limitations have been introduced for centre directors and specialists. In this context, a centre director may work at another centre within the same province (without holding the title of centre director), while other nuclear medicine specialists may work at a maximum of two centres within the same province.
• Responsible manager requirements: It is now mandatory for the responsible manager to be a Turkish citizen and to practise their profession exclusively at the healthcare institution where they are appointed.
• Sanctions: Sanctions have been tightened for centres that continue operating despite a suspension decision. In cases of continued non-compliance, the licence/operating permit shall be revoked.
• Transitional provisions: Existing centres may continue their operations; however, centres that do not meet the prescribed conditions will not be permitted to add new units.

Amendment to the regulation on the licensing of foods for special medical purposes. With the amendment that entered into force on 8 January 2026, the licensing transition period for products within the scope of the relevant regulation has been extended. Accordingly, for products that were placed on the market prior to the entry into force of the regulation upon obtaining import or manufacturing authorisation from the Agency, the licensing deadline has been extended from 31 December 2025 to 1 July 2026.

Guideline on import applications for human-derived tissues and cells and products derived therefrom. The guideline, which entered into force on 23 January 2026, regulates the procedures and principles regarding import applications for human-derived tissues and cells and products derived therefrom. In this context:

• Scope: The Guideline governs the import authorisation processes for human-derived tissues and cells and products derived therefrom, and sets out the principles regarding the issuing invoice endorsement letters for cells used in assisted reproductive techniques and cornea imports. Blood components, organs and composite tissues, products of animal/plant/synthetic origin, and certain medical devices have been excluded from the scope.
• Application procedure: Applications must be submitted by authorised centres through the electronic system. Within the scope of the application, submission of a pro forma invoice and supporting documents, either electronically or with wet signatures, is mandatory.
• Transitional provisions: Certain licences and permits may be substituted with alternative documents issued by the General Directorate of Healthcare Services until 1 January 2028.

Regulation on the organisation and conduct of activities of the turkish institute of traditional and complementary medicine. The regulation, which entered into force on 10 February 2026, regulates the establishment, organisational structure, and operational principles of the Turkish Institute of Traditional and Complementary Medicine (“TÜGET”). In this context, the establishment of three separate scientific boards within TÜGET has been envisaged, covering the fields of clinical research and projects, medical product and medical device development, and education and international cooperation. The term of office of scientific board members has been set at two years. Members may be re-appointed up to three times under the same procedure, however, the total term of office may not exceed eight years.

Regulation on cooperation in international healthcare services. The regulation, which entered into force on 14 February 2026, regulates the procedures and principles regarding cooperation between the Ministry of Health and state universities within the scope of international healthcare services. The regulation introduces a flexible assignment model that allows for planned, time-limited, or case-based assignments that will be carried out through protocols to be signed between the two institutions with respect to the relevant personnel. In this context:

• Personnel assignment: Physicians, dentists, and specialists who will provide services will be specified in an annex to the relevant protocol. Such personnel may be assigned under multiple cooperation arrangements. No separate agreement will be concluded between the service provider and the recipient institution.
• Responsibility and organisation: The assigned personnel will be responsible for diagnosis, treatment, and surgical/invasive procedures, while follow-up and support services will be carried out jointly with the relevant institution.
• Fees and financial principles: Service fees will be determined based on the Ministry tariff. Advance payment obligations have been introduced for certain patient groups, and a framework for revenue sharing has been established. After deducting the costs of medicines and medical supplies, 50% of the remaining amount will be allocated to the service-providing institution, while the balance, after applicable deductions, will be distributed among the service personnel and their team. For patients without social security coverage, at least 60% of the service fee must be collected as an advance payment.
• Reporting and other obligations: Data relating to services must be regularly reported to the Ministry via the Ministry’s Health Statistics and Causal Analysis System. Occupational health and safety obligations will be fulfilled by the recipient institution.

Guideline on the licensing of centres related to human-derived tissue and cells and products therefrom. The guideline, which entered into force on 19 February 2026, regulates and clarifies the procedures and principles regarding the preliminary approval, licensing, and inspection processes of tissue and cell centres and therapeutic biobanks. In this context:

• Establishment and licensing processes: Establishment of centres is subject to obtaining preliminary approval from the relevant provincial directorate of health. Following an on-site inspection, applications will be evaluated by the Agency and, if deemed appropriate, licences will be granted.
• Management and responsibility: The centre director must be employed on a full-time basis and meet the professional qualifications and experience requirements set out in the relevant regulation. Where the centre director also meets the qualifications of the medical director, both roles may be performed concurrently.
• Operational and quality obligations: Centres are required to comply with Good Manufacturing Practices (GMP) and meet the testing, analysis, and quality requirements set out in the relevant guidelines, in line with their scope of activities. Recall procedures and grounds have also been clearly defined.
• Inspections and sanctions: The guideline introduces detailed provisions on regular inspections of centres and stipulates that administrative sanctions will be imposed in cases of recalls and other violations, with criminal proceedings to be initiated where necessary.
• Transitional provisions: Existing centres are required to comply with the provisions of the guideline by 1 January 2027 at the latest.

Guideline on the production and quality requirements for human-derived tissue and cell products and advanced therapy medicinal products. The guideline, which entered into force on 24 February 2026, comprehensively sets out the production and quality requirements for human-derived tissue and cell products and advanced therapy medicinal products, including gene therapy products, somatic cell therapy products, and tissue engineering products. In this regard, obtaining a manufacturing license has been made mandatory for products to be used within the scope of clinical application, with such licence being valid for a period of three years. When assessed together with the Guideline on Clinical Application and the licensing framework, this development demonstrates a significant strengthening of the Turkish regulatory framework for advanced therapy medicinal products.

Amendment to the regulation on therapeutic apheresis centres and units. With the amendment dated 2 April 2026, the provisions regarding the scope of activities, organisation, and operational principles of therapeutic apheresis centres have been updated. In this context:

• Scope of activities: The definition of peripheral blood stem cell collection has been revised; it has been expressly stated that centres may carry out stem cell collection and preservation activities in addition to procedures such as cytapheresis and blood component exchange.
• Establishment and organisation: It has been stipulated that centres may not be established solely in support service areas. Furthermore, physical and organisational requirements have been tightened.
• Working regime: A full-time working requirement has been introduced for the lead specialist and the technical officer, and such persons serving in the same capacity at more than one private healthcare facility has been restricted.
• Transitional provisions: It has been set forth that working rights acquired under therapeutic apheresis certificates that have been obtained as per the previous regulation will be preserved.

Amendments to the social security institution healthcare implementation communiqué.
Various amendments – the most recent being dated 8 April 2026 – have been introduced to the Social Security Institution Healthcare Implementation Communiqué. Within this scope, co-payment amounts for medical examinations and pharmaceuticals have been increased, and certain limitations and practices relating to the provision of healthcare services have been updated. In addition, treatment criteria, reimbursement conditions, and provisions concerning medical products have been revised, while changes have also been made to the pharmaceutical pricing and discount system, including the simplification of the internal reference pricing mechanism.