Merck group
EU Regulatory Reforms to Impact the Global Life Science Industry
Emily Madigan
Every pharmaceutical and biotechnological company that currently sells or sponsors products in the European Union is influenced by the ongoing European regulatory changes. By taking a proactive approach to monitoring and tracking regulatory developments and understanding their independent and integrated impact on businesses, companies can become well equipped.
An Overview of EU Regulatory Reforms
New updates in the EU regulatory framework include international organisation for standardisation (ISO) and IDMP standards, medical devices regulation, In-vitro diagnostics regulation, ISO ICH PV E2B standards, clinical trials regulation, annex 21 and other annexes, ISO and ICH standards and quality metrics, data integrity, veterinary legislation, and general data protection. Collaboration, traceability, simplification, innovation, and harmonisation are the major aspects of these regulatory reforms.
Identification of Medicinal Products (IDMP) Data Standards
ISO, regulators, trade associations, and other stakeholders are developing and executing IDMP data standards to meet worldwide demand for internationally harmonised specifications for medicinal products. Pharmaceutical companies are required to electronically update detailed product data and maintain it continuously in accordance with the IDMP standards.
Clinical Trials Regulation
To improve the way clinical trials are applied, assessed, and monitored in the EU, the clinical trials regulation directs the EMA to deliver, update, and maintain numerous IT platforms and systems. It was observed that, previously, a great number of life sciences companies adopted a more transparent and open policy for their clinical trial outcomes without considering whether they led to positive or negative results.
However, now organisations are insisting on preparing and introducing training on new SOPs, adapting clinical trial application processes, executing a suitable system for notifications, and monitoring member state-level implementation.
Medical Devices Regulation
The objective of medical devices regulation is to protect appropriate and timely access to innovative devices for both medical professionals and patients, to enhance coordination between EU member states and rebuild public trust. To shift to the new regulation, manufacturers will be required to carefully contemplate the impact and the economic implications of the new and rigid need for medical devices and make an early decision.
Enhanced EudraVigilance System
The latest EU pharmacovigilance legislation needs the EMA to improve EudraVigilance to deliver simplified reporting, enhanced searching, and better quality data, analysis, and monitoring operations, and shift to the new ISO International Conference on Harmonisation (ICH) and individual case safety report (ICSR) standard.Implementing the updated ICSR standards will necessitate critical efforts such as system upgrades, business process reviews, and database user coaching.
Falsified Medicines Directive
One of the major issues faced by every country is the repercussions of prevalent falsified medicines in the industry.
It poses a consequential health threat, which was one of the driving forces for the EU to adopt directive 2011/62/EU. This directive is also known as the falsified medicine directive or FMD. According to FMD, every pharma and contract manufacturer, parallel traders, and re-packagers should ensure that they have transitioned their packaging lines and systems to comply with the delegated act by the deadline.
Moreover, they must also manage and exchange highly sophisticated sets of production insights and serialisation data with their supply chain business collaborators.
International Conference on Harmonisation (ICH) Q12
ICH Q12 is introduced to address the gaps present in the ICH quality guidelines Q8-Q11 by enabling more productive and efficient management of Chemistry Manufacturing and Controls (CMC). It will also allow changes in post-approval conditions while promoting continual improvement, leveraging quality, and offering a reliable supply of products. The requirement from companies is to plan for the implementation of a repository and global dossiers with defined design parameters as well as prepare for global alignment.
By taking a proactive approach to monitoring and tracking regulatory developments and understanding their independent and integrated impact on businesses, companies can become well equipped
Annex 21-Importation of Medicinal Products
Concerns regarding licences for imported medicinal products manufactured in countries outside the EU supply chains to the EU domain are addressed in the new annex 21 to the EU GMP guidelines. After the guidance is finalised, businesses have to determine whether more than one licence is needed if several manufacturing facilities are involved in developing a drug and also validate if the definition of an importer is applicable.
Manufacturing Quality Metrics
The quality metrics technical conformance guide highlights the recommended data that the organisation should update to the FDA and clarifies FDA expectations for the quality of the metrics required. Therefore, companies are required to review and align internal processes and IT systems, determine the expenses required for adopting IT platforms, and validate and prepare for optional metrics.
Veterinary Product Proposals
Another major transformation caused by the introduction of the new legislation is observed in the sector of veterinary medicinal products (VMP). The updated directive is modelled to augment the availability of VMP throughout the EU while also minimising administrative burden. Moreover, it will handle the peril of antimicrobial resistance (AMR) by managing the availability of antimicrobials for use in animals. With this new legislation, businesses require finding the possibilities for partnerships within the industry, assessing the VMP proposals’ effects on ISO IDMP standards, and cohering to new requirements to combine eSubmission data into product databases.
While examining the contemporary condition, the EU life sciences regulatory landscape is evolving rapidly and irreversibly. Therefore, it is essential for companies to track and monitor legislative and industry advancements as the changing environment holds significant licence-to-operate implications for both medical device and pharmaceutical companies, particularly those that supply products to the EU. Manufacturers, distributors, providers, and other stakeholders should assess the individual and collective effects of new legislation and adopt a proactive strategy to manage regulatory change regardless of continuous fluctuations in the timeline.
