The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the
medical regulatory law in the European Union, which should cover more and more
new legal problems related to the increasingly common application of advanced
solutions of artificial intelligence, machine learning, telemedicine solutions
and cyber solutions to the technology of manufacturing medicinal products.
In the current legal status, however, the legality of
the use of such state-of-the-art AI and machine learning technologies in pharmaceutical
production should be assessed on the basis of the regulations on the assessment
of their final effect, i.e. the level of admissibility of placing ready-made
alternative therapy products on the market, as well as the legal aspects of
commercialization of such technologies.
Laboratory research in science and medical setting.
The 26th of May 2021 will mark the first day that the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (later ‘Regulation 2017/745’) will fully apply after the 4 years transitional period. This regulation concerns medical devices – that are also regulated in Poland in the Medical Devices Act of 20 May 2010 (later MDA).
Medicinal Products, on the other hand, are regulated in Poland in the Pharmaceutical Law Act of 6 September 2001 (later PLA). Medicinal products are also regulated by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (later ‘Directive 2001/83/EC’) and the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (later ‘Regulation 726/2004’).
Article 117 of the Regulation (EU) 2017/745 introduces significant changes for some combination products.
Polish Medical Research Agency is the Polish state agency whose tasks include development of scientific research in the field of medical and health sciences. Its main goal is to build an innovative healthcare system, which will contribute to a better way of meeting society’s needs through assessing which new medical technologies and therapeutic methods should be used.
Currently, the Agency implements one of the first public grant programmes that finances non-commercial clinical trials in Poland. The Agency has planned five calls for proposals for the year 2021 – two which have recently closed, concerning clinical research in rare diseases and creating and further developing Clinical Research Support Centres, and three the details of which are yet to be announced, concerning clinical research in psychiatry and neurology (second quarter of 2021), development of innovative therapeutic solutions that use the RNA technology (May 2021) and prevention and curing of civilisation diseases (third quarter of 2021).
Polish Clinical Research Development Centre
The development of the Polish Clinical Research Support Centres is one of the projects of the Clinical Research Development Centre. The main goal of CRDC is to initiate and support the activities that aim to remove the barriers in clinical research development in Poland. From its beginnings, the Centre has been analysing and defining the scope and direction of changes to optimise the clinical research market in Poland and supporting the development of said research.
The Medical Research Agency (MRA) is a Polish state agency, which tasks include development of scientific research in the field of medical and health sciences. Its main goal is to build an innovative healthcare system, which will contribute to a better way of meeting society’s needs through assessing which new medical technologies and therapeutic methods should be used.
Currently, the Agency implements one of the first public grant programmes that finances non-commercial clinical trials in Poland. The Agency has planned five calls for proposals for the year 2021 – two which have recently closed, concerning clinical research in rare diseases and creating and further developing Clinical Research Support Centres, and three which details are yet to be announced, concerning clinical research in psychiatry and neurology (second quarter of 2021), development of innovative therapeutic solutions that use the RNA technology (may 2021) and prevention and curing of civilisation diseases (third quarter of 2021).
Clinical Research Development Centre
The development of aforementioned Clinical Research Support Centres is one of the projects of the Clinical Research Development Centre (CRDC). The main goal of CRDC is to initiate and support the activities that aim to remove the barriers in clinical research development in Poland. From its beginnings, The Centre has been analysing and defining the scope and direction of changes to optimise the clinical research market in Poland and supporting the development of said research.
On 20 – 22 April, 2021 KG Legal founding partners, Małgorzata Kiełtyka and K. Jakub Gładkowski are participating in the Conference The health + wealth of America initiative held.
