The Association of Research-Based Pharmaceutical Companies (AİFD), having completed its restructuring efforts to now have a more efficient organization, is committed to work in close cooperation with all the stakeholders as a reliable partner in health-care. The focus of our efforts is, as it has always been, on facilitating the access of our patients to new and more effective therapies. We will work toward surmounting the challenges facing us, using cooperation and dialogue and never losing sight of this core focus.

In this context, I would like to draw attention to an issue, which has been on the agenda since last year, whose grave ramifications are being felt in greater magnitude by the day. According to a circular notice issued by the Ministry of Health on 31.12.2009 concerning the Good Manufacturing Practice (GMP), registration applications submitted without a GMP certificate, recognized or issued by the Ministry for the manufacturing site, are being rejected since 01.03.2010 without even pre-evaluation.

Currently, the registration dossiers for 287 imported products of the AİFD members are awaiting processing and approval, as, the authorities state, these are required to undergo GMP inspection for approval. In fact, 162 of these applications had been submitted before the issuance of the Regulation Decree on 22.04.2009 which introduced the GMP requirement.

The AİFD, upholding its mission of working together with all the stakeholders for a healthier life in Turkey, deeply regrets this situation, I must say, where the access of our patients to new and effective medicines is restricted.

We respect the Ministry of Health’s demand for reciprocity in its dealings with competent authorities of other countries. However, for the benefit of Turkish patients and for the sustainability of new product supply in Turkey, an interim solution must be found to the process that will remove the current blockage, together with a long-term solution to minimize the delays experienced in the regulatory approval procedures for new therapies.

From this perspective, I can outline our proposal to the Ministry of Health as follows:

1. Completion of the GMP certification procedure should be ensured within 210 days, the timeframe set by the Ministry for regulatory approval, by allowing simultaneous submission of the regulatory dossier with the GMP inspection master dossier.

2. Both dossiers should be processed, and in order to facilitate patient access, the registration dossiers of original products without a generic in Turkey, which have no further incompleteness in their respective dossiers, should be approved during the course of the GMP certification procedure, if a GMP certificate, recognized by international agencies like the FDA or EMEA, is also submitted.

3. GMP certification of the current backlog of pending registration applications by the Ministry of Health should be completed in an orderly manner, prioritizing original products without a generic, as it is in the interest of patients.

4. With due regard for the principle of retrospective inapplicability of regulatory dispositions, GMP inspection should not be required of products that had been registered prior to 22.04.2009, and the products for which a registration application had been submitted prior to the aforesaid date should be processed according to the Registration Regulations that were in effect before then.

5. The GMP inspection and documentation requirements should be aligned with the prescriptions of the guidelines of the EU and FDA, the US Food and Drug Administration.

The Association of Research-Based Pharmaceutical Companies (AİFD), representing 37 research-based pharmaceutical companies, have always put its international know-how in the service of Turkey, and shall continue to do so in the future in an open manner for dialogue and cooperation. We will continue to work for long-term, predictable and transparent policies, and for the preeminence of international standards in the pharmaceutical sector. The AİFD will remain a reliable partner and a stakeholder, supporting solutions that will clear the way for our sector.

With my wishes for a healthier life in Turkey, and a healthier pharmaceutical industry.

Alp Sevindik

Secretary General