07.09.2021

DRA’s organisation is developing – Jussi Rysä has been appointed Unit Head

His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.

03.09.2021

DRA joins effort to establish the world’s first professorship in sustainable development in pharmacy in Finland

We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.

25.08.2021

MDCG has released guidance for performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVD) 

The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. 

25.08.2021

The Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices 

The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland. 

29.06.2021

Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.

29.06.2021

SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.

29.06.2021

Experienced experts and fresh top performers join our DRA team

During this spring, many experienced experts and fresh top performers have joined our team. The team of Marketing supervision and Medical services has been complemented with two new top experts. Kati Mönkkönen, Ph.D., has years of experience in the pharmaceutical industry, e.g. from Sanquin and Biogen. Her experience especially covers medical assignments. Anna Hiltunen, who […]

02.06.2021

Our Health Technology expertise is increasing further

Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.

02.06.2021

Electronic product information – where are we at?

When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is.

25.05.2021

Zero day MRP/RUP in Iceland

IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).

18.05.2021

Cycling Day 2021 – doing good for the benefit of young people’s mental health

The charitable exercise day will take place on 19 May.

10.05.2021

CMDh: Dexamethasone for the treatment of COVID-19

CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.

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