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comite de medicamentos huerfanos

English translation: Community Register of Orphan Medicinal Products for Human Use

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:comité de medicamentos huérfanos
English translation:Community Register of Orphan Medicinal Products for Human Use
Entered by: mónica alfonso
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01:10 Oct 30, 2001
Spanish to English translations [PRO]
Spanish term or phrase: comite de medicamentos huerfanos
I know they are called orphan drugs, but I wondered if anyone knew the correct translation of this committee (eurodicautom is down)
Linebyline
United Kingdom
Local time: 07:13
Community Register of Orphan Medicinal Products for Human Use
Explanation:
At the time of publication of this 1999 document, an "orphan drugs designation committee" was proposed. However, a serach for "orphan drugs committee" yielded not hits.

http://www.europarl.eu.int/stoa/publi/167780/default_en.htm
The proposed European Regulation contains the following topics:

Promulgation of an Orphan drug status for drugs treating diseases with a prevalence criterion of 5 per 10 000 inhabitants and a profitability ceiling. Medicines can also be designated as orphan drugs if the number of people affected is greater than 5 of 10 000, in the case of diseases which are transmissible, life-threatening or leading to invalidity. ... There will be an orphan designation committee.
The new Orphan drugs evaluation will be conducted by the EMEA within 60 days after the filing of the registration dossier.

However, further searches yielded the Community Register described at this address. http://pharmacos.eudra.org/F2/register/orphreg.htm


http://www.fda.gov/cder/handbook/orphan.htm
FDA's Office of Orphan Products Development coordinates research study design assistance for sponsors of drugs for rare diseases [Notice: This link will take you outside the CDER web site].

Selected response from:

Barbara Thomas
United States
Local time: 02:13
Grading comment
Thank you,
Jo
4 KudoZ points were awarded for this answer

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Summary of answers provided
5Community Register of Orphan Medicinal Products for Human Use
Barbara Thomas
4Orphan Drug Committee
David Meléndez Tormen


  

Answers


24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Orphan Drug Committee


Explanation:
Hello,

As far as I could find, it is "Orphan Drug Committee". Check the references below.

Good luck!


European Union (EU) Sets Up "Orphan" Drug Program. The EU now has its own "Orphan" Drug Act, modeled on the program established in the USA over ten years ago. Its purpose is to encourage drug companies to pursue rare disease research and coerce them to make useful molecules available, even if they are not profitable. The European Parliament has passed legislation which will establish an Orphan Drug Committee within the European Medical Drug Agency. The Committee will grant orphan drug status to appropriate substances. Once the label has been applied, pharmaceutical firms will receive a number of incentives when developing the drug, such as cheaper patenting, subsidies, and long exclusive licensing periods. (Abstracted from French Advances in Science and Technology, December 23, 1999).
(http://www.astmh.org/newsltr/news04-00/curtrends.html)

Cambridge Antibody Technology Group

Cambridge Antibody Technology Group announced that its compound, CAT-152, an antibody to prevent scarring after eye surgery, had shown long lasting and positive benefits but based on a small sample. CAT has received a positive opinion from the European Medicines Evaluation Agency Orphan Drug Committee and expects written confirmation from the European Commission soon. The new data on CAT-152 covering the two-year results from clinical trials for 24 patients, are being presented at the Association for Research in Vision in Ophthalmology 2001 conference.

(http://www.nwbrown.co.uk/camindex/0034_01.asp)

David Meléndez Tormen
Spain
Local time: 08:13
Native speaker of: Native in SpanishSpanish
PRO pts in pair: 475
Login to enter a peer comment (or grade)

44 mins   confidence: Answerer confidence 5/5
Community Register of Orphan Medicinal Products for Human Use


Explanation:
At the time of publication of this 1999 document, an "orphan drugs designation committee" was proposed. However, a serach for "orphan drugs committee" yielded not hits.

http://www.europarl.eu.int/stoa/publi/167780/default_en.htm
The proposed European Regulation contains the following topics:

Promulgation of an Orphan drug status for drugs treating diseases with a prevalence criterion of 5 per 10 000 inhabitants and a profitability ceiling. Medicines can also be designated as orphan drugs if the number of people affected is greater than 5 of 10 000, in the case of diseases which are transmissible, life-threatening or leading to invalidity. ... There will be an orphan designation committee.
The new Orphan drugs evaluation will be conducted by the EMEA within 60 days after the filing of the registration dossier.

However, further searches yielded the Community Register described at this address. http://pharmacos.eudra.org/F2/register/orphreg.htm


http://www.fda.gov/cder/handbook/orphan.htm
FDA's Office of Orphan Products Development coordinates research study design assistance for sponsors of drugs for rare diseases [Notice: This link will take you outside the CDER web site].




    Reference: http://www.fda.gov/cder/handbook/orphan.htm
    www.europarl.eu.int/stoa/publi/167780/default_en.htm, pharmacos.eudra.org/F2/register/orphreg.htm
Barbara Thomas
United States
Local time: 02:13
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 309
Grading comment
Thank you,
Jo
Login to enter a peer comment (or grade)




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