8 Amendments of Cristian-Silviu BUŞOI related to 2023/0131(COD)
Amendment 54 #
Proposal for a regulation
Recital 35
Recital 35
(35) The Agency’s scientific committees should be able to delegate some ofsupported for their evaluation duties toby working parties which should be open to experts from the scientific world and appointed for this purpose and by additional experts drawn from the pool of accredited experts, whilst retaining complete responsibility for the scientific opinions issued by them.
Amendment 56 #
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. Their evaluation will continue to encompass all the necessary expertise for each product as part of the rapporteur teams, with the possibility for CHMP and PRAC to call upon additional scientific experts to provide specific input and advice on specific aspects raised during the evaluation. In addition patients and healthcare professionals will be part of the pool of experts and will also be brought into EMA’s work according to their expertise in a certain disease area. The CHMP and PRAC consists of experts from all Member States while working parties and expert groups consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 66 #
Proposal for a regulation
Recital 51
Recital 51
(51) AGiven that the marketing authorisation holder has to forthwith submit any new data that might impact the benefit-risk balance of its products and given that the Agency has several tools available to continuously monitor the benefits and risks of authorised medicines, such as assessment of PSURs, signal detection and referrals, regulatory action will be taken as needed throughout the lifecycle of the product. Therefore, as a general rule a marketing authorisation should be granted for an unlimited time; however, one renewal may be decided only on justified grounds related to the safety of the medicinal product.
Amendment 94 #
Proposal for a regulation
Recital 87 a (new)
Recital 87 a (new)
(87 a) For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, with a view to enabling earlier availability for patients, the Agency should be able to perform a ‘phased review’ of data packages concerning finalised tests and trials before a formal application for marketing authorisation is submitted, to allow a more efficient assessment of medicinal products, while guaranteeing a high level of human health protection.
Amendment 116 #
Proposal for a regulation
Recital 132 a (new)
Recital 132 a (new)
(132 a)To ensure medicines’ access to innovative medicines, it is appropriate to establish common rules for the testing and authorisation of innovative medicinal products and innovative technologies related to such products that, due to their exceptional nature or characteristics, are expected to not completely fit the EU medicines regulatory framework.
Amendment 117 #
Proposal for a regulation
Recital 132 b (new)
Recital 132 b (new)
(132 b)Regulatory sandboxes may be set up when it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product, and those characteristics or methods positively and distinctively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major advantage contribution to patient access to treatment.
Amendment 118 #
Proposal for a regulation
Recital 132 c (new)
Recital 132 c (new)
(132 c)The objectives of the regulatory sandboxes should be: for the Agency and national competent authorities to increase their understanding of technical and scientific developments, to allow developers in a controlled environment to test and develop innovative medicinal products and related technologies that are not fitting the current regulatory framework, as agreed with the competent authorities, and to identify possible future adaptations of the legal framework.
Amendment 120 #
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxesIt is important to ensure that SMEs and startups can easily access sandboxes in order to be able to contribute with their knowhow and experience. Regulatory sandboxes are controlled frameworks that provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. They allow the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis and in exceptional circumstances a degree of flexibility in relation to testing innovative technologies, for the benefit of bringing these products to patients without compromising the standards of quality, safety and efficacy. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.