On April 4th, 2017, in Republic of Moldova the first Steering Committee Meeting of the EU-funded Twinning Project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was held for the purpose of reviewing the progress made under the project as well as to discuss results achieved and problems occurred. The Project Steering Committee also discussed the draft of the 1st Quarterly Report for the period 12 December 2016 – 31 March 2017.
The event was chaired by the MS Project Leader Mr. Gintautas Barcys, the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania. Mr. Barcys, in his opening speech welcomed the participants and underlined the importance of the project implementation. Mr. Barcys also mentioned the positive progress of the project, as all activities took place in accordance with the Twinning Working Plan and were successfully completed.
Mr. Dumitru Saghin, Project Leader, Vice Director of the Medicines and Medical Devices Agency of the Republic of Moldova emphasized the timely and effective implementation of the project during the reporting period, which leads for future steps of achieving good results of the project.
Mr. Grzegorz Cessak, Junior Project Leader, President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland expressed his gratitude to the experts for fruitful cooperation and support to strengthen the medicines, medical devices and pharmaceutical area in Republic of Moldova according to the European standards. Simultaneously he highlighted that during the project implementation and within assumed results, Members States’ side will pursue efforts to fulfill needs of Moldovan’s side in terms of regulatory standards’ adjustment, in order to achieve it we remain open for any suggestions in this matter.
The Resident Twinning Adviser – Ms. Anželika Oraitė presented the first Quarterly Report of the project, completed activities and results achieved. In her speech, Ms. Oraitė also has presented the most important statistic data regarding the project implementation in the first quarter, which are: 4 completed activities, with the involvement of 5 short-term from the Republic of Lithuania as well as MS Project Leaders and Resident Twinning Adviser in 23 mission working days, and attended by 47 experts from the Beneficiary Country.
The activities carried out throughout the first Quarter were mostly related to the analysis of the legal framework of the Republic of Moldova, the institutional and organizational capacities of the Medicines and Medical Devices Agency of the Republic of Moldova, as well as developing new tasks for the Quality Control Laboratory in order to to strengthen the functioning of the Medicines and Medical Devices Agency of the Republic of Moldova in the area of medicinal products and medical devices.
As well, representatives of other partner institutions have participated in the meeting. This included the European Union Delegation to the Republic of Moldova, the Embassy of the Republic of Lithuania to the Republic of Moldova, the Embassy of the Republic of Poland to the Republic of Moldova, the Ministry of Health of the Republic of Lithuania, the Ministry of Health of Republic of Moldova, the State Chancellery of Republic of Moldova, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland, the Centralized Procurement Centre for Health of the Republic of Moldova as well as other employees of the Medicines and Medical Devices Agency of the Republic of Moldova.
The next Steering Committee Meeting will be held on June 20th 2017.
The overall objective of this EU-funded Twinning Project is full and correct implementation of the EU acquis in the area of medicinal products and medical devices and preparation of the Medicines and Medical Devices Agency of the Republic of Moldova for joining the EU regulatory agencies network as an equal partner.
The EU-funded Project will be implemented over a 24 months period. The main purpose this EU-funded project worth 1 100 000 EUR is to strengthen the functioning of the MMDA with regards to medicinal products manufacturing, marketing, pharmacovigilance, distribution and pricing and medical devices in scope of market supervision, vigilance and registration as well as to clinical trials and pharmaceutical activity.
The completion of this EU-funded Project should deliver the MMDA with capacities at the same level as peer institutions in the EU Member States and should allow patients to benefit from safer, better quality and more effective medicinal products and medical devices.