Zulassungsphase

English translation: approval process

19:45 Aug 5, 2006

German to English translations [PRO]
Bus/Financial - Marketing / Market Research

German term or phrase: Zulassungsphase

"Zur Zeit befindet sich XYZ noch in der Zulassungsphase, ist aber schon startklar für die Markteinführung."

This is from an article about a new pharmaceutical product. Could anyone explain what "Zulassungsphase" means? I thought it meant that it was still being reviewed for approval, but it says in the same sentence that it has already been given the green light. Or am I missing something obvious here?

Many thanks

Ian

IanW (X) KudoZ activity Questions: 632 (none open) (1 closed without grading) Answers: 2731
Local time: 17:14

English translation:approval process

Explanation:
P6
http://wertpapier-analysten.de/filepools/show_file.php?pool=...

Selected response from:

Lancashireman
United Kingdom
Local time: 16:14

Grading comment

OK, thanks all round
4 KudoZ points were awarded for this answer

Summary of answers provided

4 +6

approval process

Lancashireman

3 +4

approval phase

Trudy Peters

admittance (certification) process

Raghunathan Rajagopalan

registration phase

Jonathan MacKerron

Discussion entries: 2

Answers

57 mins confidence:

peer agreement (net): +6

approval process

Explanation:
P6
http://wertpapier-analysten.de/filepools/show_file.php?pool=...

Lancashireman
United Kingdom
Local time: 16:14
Specializes in field
Native speaker of:

English
PRO pts in category: 232

Grading comment

OK, thanks all round

Peer comments on this answer (and responses from the answerer)

agree

Armin Prediger

12 mins

agree

Teresa Reinhardt: it just means that they've got their marketing concept etc. done; the only thing that's missing is the official approval

30 mins

-> Thanks, Teresa. Your added comment effectively addresses the underlying question here.

agree

jokerman: yes, "approval process" or "approval phase" - both is fine

37 mins

-> Thanks, jokerman. I agree with your comment above that the actual problem here lies with the interpretation of ‘startklar’.

agree

BirgitBerlin

45 mins

agree

Francis Lee (X): Yes, "process" rather than "phase". And as it could be ambiguous, better to insert "regulatory". In the US: "FDA approval process"

12 hrs

agree

MMUlr: maybe even more commonly used - see http://www.barrlabs.com/proprietary/approval.php

13 hrs

2 hrs confidence:

registration phase

Explanation:
might be more appropriate for your specific case

Jonathan MacKerron
Native speaker of: English
PRO pts in category: 92

1 hr confidence:

peer agreement (net): +4

approval phase

Explanation:
From the following excerpt, it looks like when the drug enters the final FDA approval phase, it has a 90% chance of success. So maybe they're assuming it will be marketed. But you're right, the sentence doesn't make sense as it stands.

As the drug moves through the development process, the risk decreases with each major milestone. The Pharmaceutical Research and Manufacturers of America reported in 2003 that drugs entering Phase I clinical trials have a 15% probability of becoming a marketable product. For those in Phase II, the odds of success rise to 30%, and for Phase III, they climb to 60%. Once clinical trials are complete and the drug enters the final FDA approval phase, it has a 90% chance of success. These improvements in the odds of success translate directly into stock value.

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Note added at 1 hr (2006-08-05 21:16:57 GMT)
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www.investopedia.com/articles/stocks/06/BiotechValuation.as...

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Note added at 4 hrs (2006-08-06 00:26:08 GMT)
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Jokerman's comment makes sense. It means the drug is ready to go (startklar) as soon as it receives approval.

Trudy Peters
United States
Local time: 11:14
Works in field
Native speaker of:

German,

English
PRO pts in category: 50

7 hrs confidence:

admittance (certification) process

Explanation:
qualification procedure. See this link for "qualification procedure"

http://www.enpirion.com/qualificationprocedures.asp.

It is ready for introduction into the market is fine. What I understand by "approval phase / process" is that the product is in final stages for being cleared. Do you really infer this from the text? I thought I can go one step below, i.e. "prior to the approval stage", i.e. the pharmaceutical product is undergoing the process of testing (qualification) for meeting the eligibility criteria.

Raghunathan Rajagopalan
Local time: 20:44
Works in field
Native speaker of: English
PRO pts in category: 2

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Zulassungsphase

English translation: approval process

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