Glossary entry (derived from question below)
Spanish term or phrase:
ERM
English translation:
Drug Registration File
Added to glossary by
Emma Goldsmith
Mar 24, 2011 16:19
13 yrs ago
8 viewers *
Spanish term
ERM
Spanish to English
Medical
Medical: Pharmaceuticals
registration number
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!
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!
Proposed translations
(English)
3 +1 | Drug Registration File | Charles Davis |
3 +2 | ERM | Rafael Molina Pulgar |
2 | MRA (Microbiological Risk Assessment) | Ron Hartong PhD (X) |
Proposed translations
+1
2 hrs
Selected
Drug Registration File
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.
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.
Note from 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 comment(s):
agree |
FVS (X)
: Great research.
47 mins
|
Thanks very much, FVS :)
|
4 KudoZ points awarded for this answer.
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.
"
+2
20 mins
ERM
Es posible que se trate del departamento o unidad encargada. Yo lo dejaría tal cual.
Note from asker:
Thanks for your suggestion, Rafael. |
Peer comment(s):
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.
|
36 mins
MRA (Microbiological Risk Assessment)
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.
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.
Note from asker:
Thanks for your input, Ron, but my report isn't about microbiology. Otherwise it would have been an excellent option :) |
Reference comments
31 mins
Reference:
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.
If it is that important, ask the client.
Discussion
Nevertheless, I am only guessing since I have no experience with the bureaucratic aspects of drug registration.
Talking about bureaucracy, I do think that we are dealing with some sort of registration number here (as you suggested yourself), and it might be best not to change it at all, whatever ERM may stand for.
It is not my intention to defend my entry (in fact I think Charles' suggestion makes more sense), but wouldn't you want to be sure that infusion products, or almost any other drug for that matter, are sterile? That's the microbiological angle I saw, but I admit that perhaps it's a bit simple-minded.
The WHO have a lot of these.
ERM – Estrategia revisada en materia de medicamentos de la OMS