Regulatory
A recent temporary authorisation under Regulation 174 issued under certain terms and conditions for physically supplying a vaccine in the United Kingdom was for Pfizer. The terms and conditions included: ■This temporary Authorisation under Regulation 174 permits the supply of identified product batch within specific time frame and specified region. For example, this authorisation applies to supply within the United Kingdom of Great Britain and Northern Ireland.
■As provided in Regulation 174A (2) of the Human Medicine Regulations, the sale or supply of this vaccine will not be deemed authorised if the supply is for the purpose of any use other than the recommended or required use, or if a condition in this authorisation is breached;
■Pfizer Limited and BioNTech Manufacturing GmbH will be jointly and separately responsible for placing the product on the market in the United Kingdom for the purposes of The Human Medicines Regulations including Reg 345(3) (hereinafter “Pfizer/BioNTech”);
■Pfizer/BioNTech are jointly and separately responsible, with the manufacturers of the product, for the conditions relating to the manufacture of the product and to product release to the market under the terms of this authorisation;
■Pfizer/BioNTech is not only responsible for compliance with the conditions expressly applied to it in this authorisation but also, where the conditions apply legislation or guidance that confers responsibilities on marketing authorisation holders, for compliance with any responsibility however worded that applies to a marketing authorisation holder in the applied legislation or guidance;
■Pfizer/BioNTech must promptly provide to MHRA any further data that is generated by them, or which otherwise come into their possession, which is relevant to the risk / benefit profile of the product;
■Pfizer/BioNTech must respond in a timely manner to any requests for further supplementary data relating to product;
■Any deviations from any of these conditions can only be made with the prior agreement of the MHRA;
■MHRA may review and adjust these conditions for temporary supply in response to any developments which it considers material, including any subsequent market authorisations that might be issued by other medicines regulators;
■This authorisation will be valid until expressly withdrawn by MHRA or upon issue of a full market authorisation by the MHRA.
individually by the competent authority of each member state. In response to managing Covid-19 emergencies, the EU has issued an implementing act restricting the export of PPE from the EU, and recommended conformity assessment procedures within the context of the Covid-19 threat. As mentioned earlier, regulatory authorities tend to provide additional resources to deal with pandemics, and on the same lines, the European Commission issued new guidance documents on the performance of Covid-19 test methods and devices, as well as performance criteria. With Covid-19, as the required IVDs are self-certified according to the In Vitro Diagnostic Medical Devices Directive (IVDD), it has been highly recommended that manufacturers placing these IVDs on the EU market review and apply these guidance documents, which include considerations on device performance and the validation of it.
“Certain humanitarian considerations and concession provisions had to be made to expedite the transition of new technologies from research and development to regulatory approval and manufacturing – making them clinically available for the diagnosis, treatment and management of Covid-19.”
Dr Gabriel Adusei
Recommendation (EU) 2020/403. The marketing of these devices is permitted if certain criteria are met, but this only applies to equipment intended to protect healthcare professionals from the SARS- CoV-2 virus. For example, Article 59 of the EU MDR (2017/745) can be used where the European Commission is responsible for identifying and authorising certain medical devices and PPE that may be sold without CE Marking during the public health emergency, and where market access is granted
22
A cautionary note on relaxing regulation The level of regulatory flexibility seen since the pandemic began is unprecedented and has led many in the medical device industry to question whether the concessions made over the past few years should lead to a softening of the rules. If there is such a time for the relaxation of regulations, this might not be it. Although certain considerations and risk-based regulatory approaches can be adopted, this is simply because in any given pandemic, there are so many uncertainties around the situation at hand. Certain humanitarian considerations and concession provisions had to be made to expedite the transition of new technologies from research and development to regulatory approval and manufacturing – making them clinically available for the diagnosis, treatment and management of Covid-19. But inspiration taken from the swift response from the regulatory agencies in assessing the impact of the pandemic and offering concessions on humanitarian grounds should not be misconstrued as loosely applying the regulations. That would have led to unreliable IVD test kits and other medical devices reaching the public. The dangers of unreliable tests, unvalidated processes and loosely regulated medical devices reaching the public or clinical setting cannot be overstated. To put it bluntly, the deleterious effects of unreliable tests reaching the public or clinical setting could be catastrophically deadly and economically devastating.
A better question to ask is: how can innovation in regulatory science inform the regulatory process to facilitate the development of new vaccines and approval of new medical technologies? The balance of the urgency of developing and approving new
Medical Device Developments /
www.nsmedicaldevices.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128
