Translating Pharmaceutical documents and regulations.
Thread poster: Luke Mersh

Luke Mersh  Identity Verified
United Kingdom
Local time: 04:42
Spanish to English
Nov 30, 2015

Dear Collaegues,

Please could you tell me where to start for translating pharmaceutical documents so they are upto date with current regulations, as I was asked if I could do so but had to decline as I do not know about the regulations;
I would like to learn, so I can in the future.
Would appreciate any help or advise on this.
regards


 

Elif Baykara Narbay  Identity Verified
Turkey
Local time: 06:42
German to Turkish
+ ...
Agency websites Nov 30, 2015

For Europe, visit the EMA (European Medicines Agency) website and the websites of national regulatory agencies.
For US, visit FDA pages.

Make sure to have a look at https://alexandria-translation-resources.com/

They are great!

Plus: http://www.proz.com/forum/german/295246-adventsaktion_gratis_dgt_und_ema_autosuggest_dateien.html


 

Luke Mersh  Identity Verified
United Kingdom
Local time: 04:42
Spanish to English
TOPIC STARTER
pharmaceutical regulations Dec 2, 2015

@Elif,
Just looking at EMA, mind boggling....
So many regulations, I do not know where to start.

I don't know what even to look for.
regards


 

Eileen Cartoon  Identity Verified
Local time: 05:42
Italian to English
Actually Dec 2, 2015

whether they are up to date with current regulations is not the job of the translator but the internal Regulatory Affairs officer. You have to translate the texts they give you. Whether they are up to date is IMHO not part of the "translation".

Eileen


 

Elif Baykara Narbay  Identity Verified
Turkey
Local time: 06:42
German to Turkish
+ ...
:) Dec 4, 2015

Luke Mersh wrote:

@Elif,
Just looking at EMA, mind boggling....
So many regulations, I do not know where to start.

I don't know what even to look for.
regards



@Eileen is right to some extent.

I was not thinking of "really learning all the regulations".

When you translate medical files or regulatory files, there are some rules you have to follow. These may be related to the file style (fonts etc.) and content. Style is something you do not need to think of as long as you do not modify the source file. It is the job of the regulatory affairs department.

When it comes to the content, of course, you don't need to learn the "regulations" regulations unless you have a personal interest icon_smile.gif

You need to know about CTD and the corresponding titles, section names etc. in your target language. Even though you are able to translate a phrase, there are already approved and required phrases in place (e.g. patient information leaflets). You have to know these details. One example:

"patient information leaflet" when literally translated into turkish is "hasta bilgilendirme broşürü".
But, the correct term adopted by MoH is "kullanma talimatı" (which is the literal translation of "instructions for use").

The link below may provide a starting point:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp


 

Siegfried Armbruster  Identity Verified
Germany
Local time: 05:42
Member (2004)
English to German
+ ...
You have to learn the regulations - it is your job Dec 4, 2015

It is your job to know which regulations apply to these texts. If you don't you will get this type of jobs only twice - the first time and the last time.

There is a nice video available that might help you to get an idea what is required.

https://alexandria-translation-resources.com/product/video-ema-templates-and-terminology/

[Edited at 2015-12-04 09:37 GMT]


 

Luke Mersh  Identity Verified
United Kingdom
Local time: 04:42
Spanish to English
TOPIC STARTER
Thank you Dec 4, 2015

Elif Baykara wrote:

Luke Mersh wrote:

@Elif,
Just looking at EMA, mind boggling....
So many regulations, I do not know where to start.

I don't know what even to look for.
regards



@Eileen is right to some extent.

I was not thinking of "really learning all the regulations".

When you translate medical files or regulatory files, there are some rules you have to follow. These may be related to the file style (fonts etc.) and content. Style is something you do not need to think of as long as you do not modify the source file. It is the job of the regulatory affairs department.

When it comes to the content, of course, you don't need to learn the "regulations" regulations unless you have a personal interest icon_smile.gif

You need to know about CTD and the corresponding titles, section names etc. in your target language. Even though you are able to translate a phrase, there are already approved and required phrases in place (e.g. patient information leaflets). You have to know these details. One example:

"patient information leaflet" when literally translated into turkish is "hasta bilgilendirme broşürü".
But, the correct term adopted by MoH is "kullanma talimatı" (which is the literal translation of "instructions for use").

The link below may provide a starting point:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp


Thank you,
I will look at this in detail.


 

Christine Andersen  Identity Verified
Denmark
Local time: 05:42
Member (2003)
Danish to English
+ ...
Emma Goldsmith's blog Dec 4, 2015

I follow Emma Goldsmith chiefly for her advice on Trados Studio, but the medical translation sections are excellent too - and she works with Spanish.

http://signsandsymptomsoftranslation.com/

Try that for sound, readable and very relevant advice.


 

Elif Baykara Narbay  Identity Verified
Turkey
Local time: 06:42
German to Turkish
+ ...
I agree Dec 4, 2015

Christine Andersen wrote:

I follow Emma Goldsmith chiefly for her advice on Trados Studio, but the medical translation sections are excellent too - and she works with Spanish.

http://signsandsymptomsoftranslation.com/

Try that for sound, readable and very relevant advice.



Shame that I never thought of naming a blog!

I follow her with great enthusiasm! Always something nice and relevant to read.


 


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