On 24 January 2023, the US Food and Drug Administration issued draft guidance on action levels for lead in certain categories of processed foods intended for babies and children under two years of age. These action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug & Cosmetic Act. FDA will consider these action levels when determining whether to bring an enforcement action.
On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency, with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.
Starting from 31 January 2023, the Clinical Trial Information System, provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area countries. The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.
On 3 January 2023, the Health Sciences Authority (HSA) issued an update on products found and reported by overseas regulators to contain potent ingredients that are prohibited and may cause side effects. The HSA published a consolidated list of health products that were found and reported by health regulators overseas (including regulators in Brunei, Canada and Hong Kong) to contain potent ingredients.
In December 2022, the Health Sciences Authority (HSA) detected potent ingredients in products marketed for young children and alerted the public against purchasing them. The HSA also published information on a retail-level recall in respect of an oral solution.
On 17 January 2023, State Decree nº 16,089/20231 was published, establishing and updating the take-back requirements system for packaging in the state of Mato Grosso do Sul. In summary, the decree becomes the new regulatory standard on the take-back requirements system for packaging in the state.
On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.
The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency, the ABPI, and pharmaceutical companies. It includes advice for companies to help them use social media in line with these rules and the rest of the Code, following a huge increase in PMCPA complaint cases during the COVID pandemic, and a consensus from the industry that the previous 2016 guidance on digital communications, which did not cover social media platforms, was outdated and unhelpful given today’s online climate.
The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.
Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or variations to MHRA, and MHRA will continue to review these applications via the current ECDRP process.
The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.