Knowledge of and compliance with regulations is vitally important in the development work concerning medicinal products and medical devices. Paying attention to the instructions, even in the earliest stages of product development, and preparing a regulatory strategy to expedite the product’s entry in the market yields the best results.
The Russian-Finnish Life Science Park commissioned DRA to compile the basics of certifying and licencing Life Science products into an English-language guide.
In the guide, called Guide For Medicinal Products and In Vitro Diagnostic (IVD) Medical Devices, DRA’s specialists describe the essential regulatory requirements in Finland and in the EU. The new regulation will bring the requirements for medicinal products and medical devices closer together. The first part of the guide covers provisions related to medicinal products, and the second part covers provisions related to diagnostic medical devices.
The section discussing medicinal products describes the life cycle of the medicinal product from the perspective of marketing authorisation requirements, explains some basic concepts and application processes and examines the key requirements related to monitoring the quality and safety of medicinal products. The path of medicinal products from product development to marketing authorisation, distribution and marketing to patients is comprehensively regulated and supervised.
The second half of the guide explores regulations concerning diagnostic medical devices and how to prove conformance, depending on the risk class. As the transition from directive to regulation is currently underway, the guide refers to both items of legislation and describes their key differences. Links and reference materials enable the reader to learn more about different topics.
The guide offers a general idea of the many steps and regulations in the journey of medicinal products and medical devices from development to the patient. DRA’s specialists have comprehensive knowledge of the regulations in the health technology industry and the medicinal products industry as well as products falling somewhere between the two industries, and they are able to offer strategic advice and practical guidelines to operators in the industry.
We hope that the guide will be of use to the corporate customers at the Russian-Finnish Life Science Park as well as other new product developers.
Download the English-language guide through this link.
The guide is funded by the EU, the Russian Federation and the Republic of Finland.