Is your biotech company prepared to submit translated documentation to the EMA for approval? Read about the process and the need for expert, accurate translation into foreign languages when submitting to the EMA:
While the development and commercialization of a biotech or life sciences product in the United States is supervised by the U.S. Food and Drug Administration (FDA), the exportation of products into the European Union is supervised by the European Medicines Agency (EMA), a process that involves several regulations and many time consuming steps.
Biotech and life sciences companies are chiefly focused on the drug or product development process, clinical trials, and results to receive approvals from the EMA. However, the linguistic translation of regulatory affairs into foreign languages is equally important, since the accuracy, consistency and legibility, as well as the format and layouts of the products and their labels into languages other than English can dramatically affect the timeframe for biotech products to be approved by the EMA.
All of the informational texts related to biotech products are evaluated by the EMA, which ensures that therapies, medical devices and other health-related products are approved for the EU market and fulfill strict criteria and standards, according to the agency’s Quality Review of Documents (RD) Working Group. A centralized marketing authorization from the EMA requires that biotech companies present information both in English and in other languages of official EU members, which are submitted to a linguistic review process.
“A linguistic review of product information in all EU languages is performed after the adoption of CHMP [Committee for Medicinal Products for Human Use] Opinions to ensure high quality and consistent product information of Centrally Authorized Products (CAPs) in all Member States. Such post-opinion product information linguistic review is part of the Commission Decision-Making Process (DMP),” states the regulatory guidelines of the agency.
In order to receive marketing authorization to commercialize biotech products in the EU, international biotech companies need to present Summaries of Product Characteristics (SPC), as well as Patient Information Leaflets (PIL), Labeling and Packaging, Marketing Authorization Dossiers, Expert Reports and Validation Protocols.
Just like the FDA, COMP is responsible for the accelerated development and commercialization of a product. The agency may grant orphan-medicinal-product designation to products meant to prevent, diagnose or treat life-threatening or severe rare conditions that affect less than five to 10,000 people in the EU.
Receiving the status also means that a company is granted up to 10 years of marketing exclusivity for its product in all the countries within the European Union after receiving marketing approval, as well as other benefits, such as EU-funded research, protocol assistance, and fee reductions. Despite being more difficult to obtain compared to a similar designation from the FDA, numerous American companies have already been awarded with orphan-medicinal-product designation by the EMA, as is the case of Austin-based pharmaceutical company Lung Therapeutics, Inc. and its treatment for empyema as a complication from pneumonia, LTI-01.
Regardless of the process that a biotech company undertakes in dealing with the EMA, the need for accurate, authoritative translations from English into other EU languages is critical, since shoddy translations can mean the misinterpretation of dosing, data, or other key specifications that can cause a major delay in approval.
When searching for a translation agency to handle these projects, it is critical to identify firms with prior life sciences translation experience who can guarantee that they will meet the stringent regulatory requirements and often challenging deadlines associated with these projects. In particular, look for translation agencies that have a certified quality management system in place, such as an ISO 9001:2008 certification, and who are compliant with the EN 15038 European Quality Standard for Translation Service Providers and ASTM F-2575-06 — another key set of standards that professional translators adhere to. By working with an agency that takes these standards seriously, you can be assured that the translation process will be streamlined and efficient so that translations are accurate and keep your approval processes on schedule.