The National Agency for Medicines and Medical Devices (NAMMD) is a public institution subordinated to the Ministry of Health, set up through Government Emergency Ordinance no. 72 of 30 June 2010 on reorganisation of certain healthcare facilities and amendment of public health legislation, as a result of the merger of the National Agency for Medicines and the Technical Office for Medical Devices. NAMMD organisation and operation have been approved by Government Decision No. 734 of 21 July 2010.
MISSION OF THE NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES
The NAMMD mission is to help protect and promote public health by:
– Evaluation at the highest scientific competence of documentation for authorisation in view of marketing high quality, safe and effective medicinal products for human use;
– Surveillance of the safety of medicinal products for human use in therapeutic use by means of inspection and pharmacovigilance activities;
– Ensuring access for the pharmaceutical industry, patients and healthcare professionals to useful and accurate information on medicinal products for human use authorised for marketing in Romania;
– Maintaining of a high level of performance and safety of medical devices in use by healthcare networks throughout the country, irrespective of ownership;
– Most demanding assessment of service providing medical-technical units in the area of medical devices, for optimum delivery of competent and quality prosthetic and repair – maintenance services;
– Issuing specific technical procedures in the field of medical devices;
– Ensuring institutional administrative effectiveness, efficiency and transparency of practices and procedures in use.
Vision of the NAMMD
– Strengthening of its status as reference national authority in the field of medicinal products for human use and control of the performance and safety of medical devices in use.
– Strengthening of its status as expert and reliable source of accurate and timely information in the field of medicinal products for human use, provided to stakeholders.
Strategic objectives of the NAMMD
– Protection and promotion of public health, by accomplishment of the NAMMD primary role, namely warranty of compliance of authorised medicinal products with the required standards, their efficacy and their acceptable level of safety, and warranty of compliance of medical devices with the required standards, their efficacy and their acceptable level of safety;
– Fulfilment of the NAMMD role of communication, as a permanent expert and reliable source of accurate and timely information related to the medicinal product for human use, by providing clear and timely information to healthcare professionals, patients, the pharmaceutical industry and the general public;
– Permanent contribution to the projection of the future legal frame in the field of medicinal products for human use and to the shaping of secondary legislation in the field of medical devices through maintenance, improvement and by means of increased NAMMD European and international relations;
– Coordination of an organisation endowed with quality and adequately qualified workforce, able to cope with future challenges.
For over 50 years now, the National Agency for Medicines and Medical Devices (NAMMD) has represented the medicinal product regulatory authority in Romania. Initially known as the Institute for the Control Medicines and Pharmaceutical Research, on its setup in 1956, the name of the institution was further changed in 1960, to become the State Institute of Drug Control and Pharmaceutical Research (ICSMCF) and later on, between 1999 – 2010, by reorganisation of the former ICSMCF, the institution operated as the National Medicines Agency. The National Agency for Medicines and Medical Devices (NAMMD) is established through Emergency Government Decision no. 72/2010, as result of the merger of the National Medicines Agency with the Technical Office for Medical Devices.
The ICSMCF was the first institution in Romania to comply with the modern definition of a medicines regulatory authority, whose main duties were: authorisation and registration of medicinal products, yearly development of the Product Index, complex control of medicinal products manufactured nationally and abroad, pharmaceutical inspection, development of the Romanian Pharmacopoeia and its Supplements, development of national standards and reference materials etc.
The founder and patron of this institution was Professor Dr. Petre Ionescu Stoian, who, together with his collaborators, organised a modern institution whose leader he was in exemplary professional integrity over a 20 year time span (1956-1976). In well-deserved homage, by order of the minister, the Institute was given his name, preserved until 1 January 1999, when the National Medicines Agency was established.
The National Medicines Agency (NMA) carried on ICSMCF tradition in regulation and control of medicinal product quality in Romania.
Establishment of the NMA did not stem from an institutional, scientific or professional void, but from a change in philosophy, closer to that of its EU counterparts, implying an important gradual change in vision and principles, within a process of harmonisation with the European vision and practice in the field.
The decisive step in the evolution of the National Medicines Agency as of 1999 was adoption of specific landmarks, to constantly direct its policy and practice, i.e. European landmarks, primarily those of the then newly-founded European Medicines Agency (EMEA, nowadays EMA).
On 01.01.2000, based on Order of the Minister of Health No. 802/1999, the structure of the National Medicines Agency also included the Centre for the State Control of Biological Products for Human Use, when the Agency further took upon itself the duty as Romanian competent authority in biological products for human use, resulting in additional duties and an extended range of stakeholders.
NMA main professional activities have been carried on by the NAMMD:
– Marketing Authorisation activity and related activities (approval of variations, clinical trials and advertising material for OTC products, pharmacovigilance, information concerning medicinal products);
– Medicinal product quality control activity;
– Pharmaceutical inspection activity;
– Regulatory activity under the Ministry of Health;
– Pharmacopoeia related activity;
– Quality management activity.
By the time of joining the EU in 2007, the NMA had had the opportunity to assign 26 active observers for participation as active observers in EMA scientific committees and working groups, the most efficient manner to maintain the NMA in line with European activities in the medicinal product field.
Due to Romania’s accession in 2003 to the European Convention on elaboration of a European Pharmacopoeia, the latter’s quality standards have become mandatory for all raw and starting materials as well as for medicinal products manufactured both in Romania and abroad.
In June 2006, Romania became visible on the EudraNet map, by successful NMA connection to the computer network of European competent authorities in the field of medicinal products for human and veterinary use, under permanent coordination and monitoring of the EMA.
Through its specialists appointed as members, the NAMMD currently actively participates in meetings of EMA committees and scientific working groups as well as of other bodies in the medicinal product field. This is the most effective means by which the National Agency makes an effective contribution to good progress of European activities in the field of medicinal products for human use.
The roots of ANMDM activity in medical devices go back to over 50 years ago as well.
As early as 1958, the technical directorate of the Ministry of Health set up its own laboratory for technical testing of medical equipment to be provided to the healthcare network. The laboratory operated as an independent legal entity under the Ministry of Health until 1973, when it became a technical distinct entity within the Station for Verification and Maintenance of Medical Devices (SVMMD).
In addition to the work in laboratory testing and verification activities, the institution also provides servicing of medical equipment for healthcare units directly under the Ministry of Health.
On 1 February 2005, by Law no. 176/2000 (republished), the SVMMD was reorganised under the name of the Technical Office for Medical Devices (TOMD), a modern institution making an important contribution to the transposition and implementation in Romania of the three European directives on the new approach to medical devices.
Through special efforts and call for European funds, the only medical devices certifying body in Romania was established in this institution, also notified in Brussels.
The Testing Laboratory at the same time accredited by the Accreditation Association in Romania (RENAR) under SR EN ISO 17025:2005, has undergone particular progress and contributed to maintaining within performance and safety parameters of medical devices in use on throughout Romania, as well as to testing and verification of new types of medical devices in view of their certification and application of the EC marking.
A third component of the activity of the institution has been assessment of service providing organisations in the field of medical devices. Former TOMD specialists, know-how and technical endowment are now the foundation for NAMMD activities in the field of medical devices, as regulated by Law nr.176/2000 on medical devices, republished, as amended.