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Legal Alerts

10/07/2020

Recent Developments in the Healthcare Sector

Legal Alerts
Healthcare
General

Turkish Pharmaceuticals and Medical Devices Authority Becomes ICH Regulatory Member
The Turkish Medicine and Medical Devices Authority (“TİTCK”) announced that it officially became a regulatory member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Accordingly, pharmaceuticals licensed in Turkey, clinical trials and pharmacovigilance activities carried out in Turkey meet the international standards.  The TİTCK’s announcement is available online here (in Turkish).

What’s New?

The ICH is an international organization established in 1990 by healthcare authorities in the US, the EU and Japan. The ICH’s mission is to achieve worldwide harmonization to ensure that safe, effective and high quality medicines are developed through its guidelines. Accordingly, the ICH publishes, regulates and guides healthcare regulations around the globe.

The TİTCK has been acting as an observer at the ICH since November 2017. In 2020, the TİTCK officially became a regulatory member of the ICH along with healthcare authorities in the US (FDA), the EU (EMA), Japan (PMDA), Switzerland (Swissmedic), Canada (Health Canada, Singapore (HSA), South Korea (MFDS), China (MNPA), Taiwan (TFDA), and Brazil (Anvisa) by meeting all membership criteria. As a regulatory member, the TİTCK will not only comply with the ICH’s technical guidelines, but will also contribute to the preparation of such guidelines.

The TİTCK stated that their full membership will increase the TİTCK’s reputation in the industry, and will positively affect the international trade.

Turkey Issues New Announcement on Product Promotion Representatives’ Activities During “New Normal”

The Turkish Medicine and Medical Devices Authority (“TİTCK”) announced that it re-evaluated the limitations on product promotion representatives’ activities within the scope of measures in response to the COVID-19 pandemic. Accordingly, product promotion representatives will be able to pay visits to health organizations under certain conditions. The TİTCK’s relevant letter is available online here (in Turkish).

What’s New?

According to Article 5 of the Regulation on the Promotional Activities of Pharmaceuticals, product promotion representatives carry out promotional activities for pharmaceuticals through visits to doctors, dentists and pharmacists. As part of the measures to combat the COVID-19 pandemic, the TİTCK previously announced the suspension of these visits until further announcement, and stated that promotion activities can still be carried out electronically (such as email and video conference).

According to the TİTCK’s recent announcement, product promotion representatives are now able to visit the doctors, dentists and pharmacists at the following health organizations, on the condition that they complete the relevant trainings regarding infection control, reduction of infection risk, etc.:

  • First stage health organizations providing outpatient treatment and diagnosis health services as of June 8, 2020
  • Hospitals, except for those where COVID-19 patients are treated as of June 15, 2020

During the visits, product promotion representatives must use masks, comply with social distancing and hygiene rules, complete the visit as soon as possible, and record all relevant information about every doctor, dentist and pharmacist they visit.

Supply of Limited Distribution Pharmaceuticals Used with Pharmaceutical Safety Inspection Form

The TİTCK updated the relevant procedures and actions steps for the supply of pharmaceuticals (“Limited Distribution Pharmaceuticals Used with Pharmaceutical Safety Inspection Form”) tracked by the TİTCK due to COVID-19 risks. The TİTCK published guidelines for patients and pharmacies regarding these pharmaceuticals and their supply. The guidelines are available online here (in Turkish).

The TİTCK Updated the Principles for Standard Working Methods of Clinical Trials and Bioavailability/Bioequivalence Studies Ethics Committees

The TİTCK announced that it updated the Principles for Standard Working Methods of Clinical Trials and Bioavailability/Bioequivalence Studies Ethics Committees (“Guidelines“). The Guidelines contain detailed explanations on various subjects, including the process for the establishment of an ethics committee, conditions for the appointment of ethics committee members, and the working principles and procedures of the ethics committee. The Guidelines are available online here (in Turkish).

Communication with the Pharmaceutical Licensing Department

On July 1, 2020, the TİTCK announced the principles and procedures for communications/meetings with the Pharmaceutical Licensing Department.

In principle, communications/meetings with the Pharmaceutical Licensing Department occur by making an appointment through the Electronic Document Management System. The TİTCK stated that the communications/meetings will be carried out as below:

  • Meetings with the Preliminary Assessment Unit, BA/BE Unit, Licensed Pharmaceuticals Unit, Licensed Pharmaceuticals Technological Assessment Unit and Priority Assessment Unit regarding these units’ areas of responsibility will be held with a certain number of companies on certain days of the week. The meetings will take 15 minutes for each company.
  • Companies wishing to make an appointment for meeting must fill out the form on the TİTCK’s official website and send the form to ruhsatrandevu@titck.gov.tr. The meeting requests will be evaluated by the Pharmaceutical Licensing Department, and the meeting dates will be notified to the relevant companies via email.
  • As the license applications can be tracked through the Electronic Process Management system, the TİTCK will not accept meeting requests regarding the status of the application.
  • Due to the COVID-19 pandemic, meetings will be held online until further notice.

Companies may apply to the TİTCK for appointments as of July 6, 2020. The TİTCK’s relevant announcement is available online here (Turkish).

Conclusion

The TİTCK continues taking active steps to guide companies in the healthcare sector. All relevant companies must comply with their obligations under the applicable legislation, and carefully review and follow the TİTCK’s announcements and recent developments.

Please stay up to date with further developments through the Esin Attorney Partnership Coronavirus Helpdesk.