Ministry of Health, Labour and Welfare

20 December 2013
Ministry of Health, Labour and Welfare

Registration opens for EMA/FDA/MHLW-PMDA Orphan Product Designation Workshop

Registration is open for the first workshop on orphan product designation and grants jointly organised by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).

The event will be held on Monday 10 March 2014 at the EMA, London, United Kingdom.

The aim of the workshop is to provide information to companies, as well as to academics, on the EMA, FDA and MHLW-PMDA programmes for orphan medicinal product designation as well as on the grant programmes for development of orphan medicinal products that are available. These programmes aim to promote the development of new medicines for the treatment of rare diseases.

The workshop’s morning session will provide information on these different programmes and will be broadcast live on the EMA.

The afternoon session will be dedicated to one-to-one meetings with EMA, FDA and MHLW-PMDA staff during which participants will have the opportunity to present a draft application for orphan drug designation and to discuss with the three agencies for a medicine under development that holds promise for the treatment of a rare disease.

These one-to-one sessions are intended to help participants improve the structure and content of their draft application to fit the EMA FDA and MHLW-PMDA application requirements.

There is no registration fee for attending the workshop, however registration is required. Participants can register for both morning and afternoon one-to-one sessions on the EMA website

Registration is limited to 150 participants for the morning session. Members from the European Committee for Orphan Medicinal Products (COMP) will be attending the workshop.

Related Sites Link:EMA-Medicines for rare diseases
Contact at MHLW/PMDA:Akiko Nitta at

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