Upcoming EU regulations will significantly impact the life sciences industry. Here’s what you need to know to stay compliant.
From gene therapies to drug trials, wearable health technology to the battle against COVID-19, life sciences is one of the world’s most diverse and strategically important industries, attracting investment and talent from all over the world.
The scope of life sciences is not contained by national borders or cultural boundaries. Operating at the cutting edge of global science, this highly regulated sector faces a constant challenge from changing international laws and guidelines.
This article looks at five recent regulatory developments in the European Union (EU) and how they will impact life sciences organizations operating within the EU.
1. Identification of Medicinal Products Data Standards
To facilitate the access and exchange of accurate and consistent medicinal product information, the Identification of Medicinal Products (IDMP) Data Standards revised and consolidated a group of ISO data standards: ISO 11615, ISO 11616, ISO 11238, ISO 11239, and ISO 11240.
In preparation for IDMP, these ISO standards were enhanced and updated by the European Medicines Agency (EMA) and the American Food and Drugs Administration (FDA).
A phased implementation process that began in February 2020 requires pharmaceutical companies to submit data on medicines to the EMA that is compliant with IDMP requirements, systems, and terminologies.
In creating a ‘common language’ data repository, IDMP makes a vast quantity of medicinal product information easily accessible to all branches of life sciences worldwide.
2. Clinical Trials Regulation
Procedures relating to clinical trials in the European Union (EU) will change when the Clinical Trial Regulation comes into force in December 2021. This new EU directive mandates that the EMA must establish and maintain several IT systems designed to improve how clinical trials are requested, assessed, and supervised.
The Clinical Trials Regulation aims to ensure the following:
- The highest standards of patient safety
- A streamlined application procedure via a single portal
- A single authorization procedure
- Greater legal certainty for sponsors and researchers, in particular SMEs and academics
- Increased transparency for clinical trials data
Life sciences organizations involved in research will need to prepare for these new operating procedures, which will involve training, setting up a system of notifications, and monitoring implementation in member states.
3. Medical Devices Regulation
The rules regulating the manufacture and supply of medical devices in the EU will change in May 2021 with the introduction of the Medical Devices Regulation. This directive aims to expedite access to innovative technology for patients and medical professionals.
Among the aims of the new and more stringent requirements are the expansion and clarification of the definition of what a medical device actually is. Is a software app relating to personal fitness considered a medical device, for example?
The new regulation will also impose an obligation on manufacturers to provide each device with a unique identifier to aid full traceability of components and process information.
4. Falsified Medicines Directive
The EU adopted the Falsified Medicines Directive (FMD) in a bid to fight back against the illegal trade in fake medicines. The sale of counterfeit medicines has been fueled by online shopping, where unscrupulous criminals are easily able to escape accountability.
The directive includes a range of measures to prevent purported medicines entering the supply chain that are contaminated, contain the wrong ingredient, or contain no active ingredient at all.
Measures include a unique identifier—a data matrix code and readable text—placed on medical products to be scanned at different stages along the supply chain. Manufacturers will also have to adapt product packaging to incorporate anti-tampering devices.
5. How is Brexit affecting the European life sciences industry?
The departure of the United Kingdom from the EU has had repercussions for European life sciences.
The EMA is moving its headquarters from London to Amsterdam, and several regulatory responsibilities that were based in the UK have now been assigned to EU member states.
Some international life sciences companies have chosen to alter their European distribution model, as EU members compete to tempt the lucrative businesses away from the UK.
The life sciences industry is subject to more EU legislation than most other industries within the bloc. So the consequences of a no-deal Brexit effectively tearing up these regulations for the UK would be considerable.
The repercussions would impact everything from product development to transportation. Life sciences organizations, therefore, should have contingency plans in place to mitigate the impact of these possible ramifications.
What should life sciences companies be doing now?
The previous five examples of the shifting EU life sciences regulatory landscape highlight the importance of life sciences companies being able to respond quickly to change. The international nature of the life sciences sector also means that companies need to communicate often complex, technical information to people in different countries with accuracy and fluency.
This is where many organizations turn to Summa Linguae Technologies for help.
Summa Linguae’s Production Manager Poland, Joanna Kaniecka explains the importance of taking a proactive approach to managing regulatory change. “When trading internationally, it’s not enough to simply pass medical marketing material to a translator. The ever-evolving regulatory environment requires companies to be attentive to region and country-specific challenges.”
These challenges extend beyond language and regulatory differences to include cultural differences too. “When localizing life sciences communications for specific target markets, Summa Linguae takes a holistic approach,” Joanna continues. “We consider everything from language and legal requirements to religious beliefs and social practices—all achieved while maintaining full traceability and auditability.”
In an area as strictly governed as the life sciences industry, companies must move fast and be unfailingly accurate with their international communications. This requires specialist knowledge and skills that only an expert in life sciences translation and localization can provide. To discover how your company can benefit from such expertise, contact Summa Linguae Technologies today.
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