The MPA clarifies mission through the Innovation Office
The Medical Products Agency (MPA) has initiated a long-term commitment to strengthen the organisation’s brand and thus increase the availability of the Agency’s services, especially targeted to smaller companies.
The large and international pharmaceutical developers, often called Big Pharma, are well aware of the MPA and the benefits of consulting the Agency on various issues related to the development of new drugs. The greatest need for support is tied to small, research-oriented companies, the very same companies that often represent major breakthroughs in life science.
Providing scientific advice
It is the responsibility of the MPA to give the industry advice by answering questions connected with the development of medical products based on the applicant’s documentation. Both pharmaceutical companies and medical technology developers can seek advice from the MPA.
For questions related to common guidelines, accepted ways of practice and general information about legislation tied to medical product development, the MPA will provide free support and information. For scientific advice tied to a specific development, the MPA is allowed to take out a modest fee.
Advice may thus be requested for all medical products, irrespective of subsequent choice of procedure for approval. It is important to remember that regulatory aspects are not affected by requesting scientific advice from the Agency.
It is, however, not the Agency’s role to take on the pharmaceutical industry’s responsibility for developing its products. The advice is based on in-depth knowledge and expertise, but the responsibility of developing the new products lies with each company.
Hence, we know that supporting the development of new medical products for the benefit of patients is a priority for the MPA. To clarify and develop this objective, the Innovation Office was established in January 2013.
Dr. Susanne Baltzer, Director of the Innovation Office, explains that the founding of the new innovation platform also emphasises the Agency’s mission and activities across Europe.
“The main goal of MPA is to serve patients in Sweden. It is their health and security that we focus on”, she says. “At the same time, it is important to remember that in order to gain access to safe, functional and highly reliable drugs, or other medical products, it is necessary to employ an international outlook from day one”.
Facing major changes
Sweden has a well-established tradition of globally acclaimed research within the medical sphere. There are a lot of inspiring examples of revolutionary breakthroughs originating from Swedish innovations, but despite the strong heritage it has become more common to locate clinical trials elsewhere.
“We established the Innovation Office in order to help the industry face the major changes occurring in the pharmaceutical world”, Susanne Baltzer explains. “The aim is of course to retain as much development as possible here in Sweden; and we must support the development particularly in the smaller companies since they are often responsible for much of the fundamental R & D on behalf of the larger, global players”, she concludes.