On 20th June 2017, the second 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 reviewing the progress made under the project.
The event was chaired by Mr. Vladislav Zara, the General Director of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA), whom highlighted the importance of the EU-funded Twinning project which “offers a great support to the Medicines and Medical Devices Agency of the Republic of Moldova in its way of strengthening capacities for joining the EU regulatory agencies network as an equal partner”.
Project Leaders Mr. Gintautas Barcys, Mr. Dumitru Saghin, and Mr. Grzegorz Cessak, emphasized the timely and effective implementation of the project activities and a good collaboration between project partners, which leads for future steps of achieving good results of the project.
The Resident Twinning Adviser Ms. Anželika Oraitė presented the most important information regarding the second quarter of the Project, which is: 6 activities, with the involvement of 30 short-term experts from the Republic of Lithuania and the Republic of Poland in 33 working days mission and attended by 150 experts from the Beneficiary Country.
During the second quarter 32 employees of the Medicines and Medical Devices Agency of the Republic of Moldova were trained on the EU regulatory framework for medicines and medical devices. Additionally, 25 employees of the MMDA were trained on EU regulatory affairs and assessment of medicinal products.
Also, development of a SOP for the authorisation of medicinal products, preparation of a report on the possibilities to improve mechanisms to ensure availability and access are under the progress and are planned to be implemented during the next quarters.
The preparation of a comparative screening list of Moldovan legal acts against the EU acquis on medicinal products and medical devices and recommendations for improvement of legislation are in progress.
For the next quarter implementation of 8 activities within 4 EU-funded Twinning project components is planned.
The next Steering Committee meeting for was fixed for 12 October 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.