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ERM

English translation: Drug Registration File

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:ERM
English translation:Drug Registration File
Entered by: Emma Goldsmith

16:19 Mar 24, 2011
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / registration number
Spanish term or phrase: ERM
I'm translating a report issued by CECMED (Centro para el Control Estatal de la Calidad de los Medicamentos) in Cuba about the registration of an iv infusion product.
At the top of the report, just below the logo, is the abbreviation ERM, followed by some numbers.
ERM: 1234/11

I think this is probably the document number / outgoing registration number (especially as 11 could be short for 2011).

Does anyone know what it stands for and how I can say it in English?
Thank you!
Emma Goldsmith
Spain
Local time: 08:33
Drug Registration File
Explanation:
In Spanish: Expediente de Registro de Medicamento

As Ron says, ERM is quite commonly found as the abbreviation of Evaluación de Riesgo Microbiológico (Microbiological Risk Assessment), but that just doesn't seem relevant here: there's no obvious microbiological angle in your report or indeed other CECMED reports on the Internet that have this reference code (of which there are a number).

I base my answer on the following document, which is the 2010 issue (no. 2) of Investigaciones ININ, the digital journal of the Cuban Instituto de Investigaciones de Normalización. It is in a contribution entitled "Modelo básico para diseñar e implantar Sistemas de Gestión de la Calidad integrando NC ISO 9001:2008 con las Buenas Prácticas de Fabricación farmacéuticas cubanas", which includes tables showing the documents required by Cuba's own BPP [Buenas Prácticas de Producción] Regulación 16/2006 and how they correspond to the ISO standard mentioned. In the list of Cuban documents corresponding to "Procedimientos para el control de los productos no conformes", we find "Expediente de registro de medicamento".
http://www.inin.cubaindustria.cu/docs/Boletin-Investigacione...

Although I do not have a document to prove that ERM in CECMED reports stands for this, I think it is very probable. It makes perfect sense in context, and describes exactly what CECMED is doing: registering drugs or medicines.

In a report of a Cuban clinical trial of "IFN alfa-2b recombinante en esclerosis multiple recurrente-remitente", for example, we find the following entries:
"Fecha de la autorización de inicio por Agencia reguladora: 1995-03-23 18:00
Número de referencia en la agencia reguladora: ERM:176/95
[...]
Agencia que registró el producto: CECMED"
http://registroclinico.sld.cu/ensayos/.2008-04-08.165143-11

By the way, it is quite clear that the number after the slash is the year, as you suspected. The number before the slash is presumably the index number, corresponding to how many such "expedientes" CECMED had issued that year.
Selected response from:

Charles Davis
Spain
Local time: 08:33
Grading comment
Thanks Charles and everyone else for your ideas on this. I tried unsuccessfully to contact the end client and so I went for this in the end, adding a note to say that I thought it meant Expediente de Registro de Medicamento.

4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2ERM
Rafael Molina Pulgar
3 +1Drug Registration File
Charles Davis
2MRA (Microbiological Risk Assessment)
Ron Hartong PhD (X)
Summary of reference entries provided
liz askew

Discussion entries: 4





  

Answers


20 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
ERM


Explanation:
Es posible que se trate del departamento o unidad encargada. Yo lo dejaría tal cual.

Rafael Molina Pulgar
Mexico
Local time: 00:33
Native speaker of: Native in SpanishSpanish
PRO pts in category: 4
Notes to answerer
Asker: Thanks for your suggestion, Rafael.


Peer comments on this answer (and responses from the answerer)
agree  liz askew
11 mins
  -> Gracias, Liz.
agree  David Brown: But for a different reason.I think it is an English acronym for Enterprise Risk Management (ERM) which is an organisation that offers guidelines for gestion integral de riesgos. Therefore it is its risk management assessment number
1 hr
  -> Gracias por tu aportación, David.
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36 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5
MRA (Microbiological Risk Assessment)


Explanation:
Hi Emma,

I'm not at all sure about this, but given the context it might mean 'evaluación de riesgos microbiológicos'.
On the other hand, I did see similar numbers (ERM: xxx/yr) pop up in more Cuban health-related documents, so maybe it's better to leave it as such, as Rafael suggested.

Ron Hartong PhD (X)
Local time: 08:33
Specializes in field
Native speaker of: Native in DutchDutch, Native in EnglishEnglish
PRO pts in category: 40
Notes to answerer
Asker: Thanks for your input, Ron, but my report isn't about microbiology. Otherwise it would have been an excellent option :)

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2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
Drug Registration File


Explanation:
In Spanish: Expediente de Registro de Medicamento

As Ron says, ERM is quite commonly found as the abbreviation of Evaluación de Riesgo Microbiológico (Microbiological Risk Assessment), but that just doesn't seem relevant here: there's no obvious microbiological angle in your report or indeed other CECMED reports on the Internet that have this reference code (of which there are a number).

I base my answer on the following document, which is the 2010 issue (no. 2) of Investigaciones ININ, the digital journal of the Cuban Instituto de Investigaciones de Normalización. It is in a contribution entitled "Modelo básico para diseñar e implantar Sistemas de Gestión de la Calidad integrando NC ISO 9001:2008 con las Buenas Prácticas de Fabricación farmacéuticas cubanas", which includes tables showing the documents required by Cuba's own BPP [Buenas Prácticas de Producción] Regulación 16/2006 and how they correspond to the ISO standard mentioned. In the list of Cuban documents corresponding to "Procedimientos para el control de los productos no conformes", we find "Expediente de registro de medicamento".
http://www.inin.cubaindustria.cu/docs/Boletin-Investigacione...

Although I do not have a document to prove that ERM in CECMED reports stands for this, I think it is very probable. It makes perfect sense in context, and describes exactly what CECMED is doing: registering drugs or medicines.

In a report of a Cuban clinical trial of "IFN alfa-2b recombinante en esclerosis multiple recurrente-remitente", for example, we find the following entries:
"Fecha de la autorización de inicio por Agencia reguladora: 1995-03-23 18:00
Número de referencia en la agencia reguladora: ERM:176/95
[...]
Agencia que registró el producto: CECMED"
http://registroclinico.sld.cu/ensayos/.2008-04-08.165143-11

By the way, it is quite clear that the number after the slash is the year, as you suspected. The number before the slash is presumably the index number, corresponding to how many such "expedientes" CECMED had issued that year.


Charles Davis
Spain
Local time: 08:33
Native speaker of: English
PRO pts in category: 136
Grading comment
Thanks Charles and everyone else for your ideas on this. I tried unsuccessfully to contact the end client and so I went for this in the end, adding a note to say that I thought it meant Expediente de Registro de Medicamento.
Notes to answerer
Asker: Thanks, Charles, I think you may well be right. I had already found your 2nd ref, and your 1st one makes it look quite likely.


Peer comments on this answer (and responses from the answerer)
agree  FVS (X): Great research.
47 mins
  -> Thanks very much, FVS :)
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Reference comments


31 mins
Reference

Reference information:
FWIW, it would take weeks to find out what this is, especially as there are no refs. on the net, that I can find. It is probably specific to Cuba too

If it is that important, ask the client.

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 716
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