Marketing Authorisation Applications

We are proud to say that the Regulatory Affairs departments of 2 of the 5 largest pharmaceutical companies in Europe
have been among our main clients for over 25 years. Their trust and loyalty best demonstrate our commitment to quality.

 

As a Marketing Authorisation Application is not a promotional document but a scientific document with legal implications, many pharmaceutical companies prefer to entrust them to specialised translators.


After 10 to 12 years of Research and Development, the drug product is finally ready to be marketed once approved by health authorities. Translating Marketing Authorisation Applications is more than a mere administrative formality, it is an essential step in the life of a drug product. Health authorities are usually understanding when dealing with a Marketing Authorisation Application of thousands of pages; however, it is quite frequent that a company is forced to delay the launch of a new product in a given country by several months because of translation issues. A reliable and scientifically-accurate translation avoids delays which could have significant economic consequences.


With constantly improving standards of living, the population is increasingly sensitive to safety and public health issues which fall under the responsibilities of public authorities. That is why they demand complete documents and professional translations. ARGOSPharma always gives priority to quality, even in stressful situations when large dossiers need to be translated within short deadlines. A deficient translation can have serious and expensive consequences for pharmaceutical companies, as indicated by the European Medicines Agency:

 

“If a translation is considered to be of unacceptable poor quality, the transmission to
the Commission will be delayed until receipt of the amended translation”.
 


EMA/583202/2012 Rev1. 5 November 2012
Procedure Management and Business Support
Practical information on translations for referral procedures (human)

 

As Marketing Authorisation Applications are increasingly voluminous and complex, pharmaceutical companies cannot but recognize the importance of eliminating redundant tasks. ARGOS Pharma is the perfect solution for this purpose because it allows centralizing all the translated material.

 

  Translation of the Common Technical Document:
ARGOS Pharma’s experience is crucial in a sensitive sector where poor quality cannot be tolerated.
 



The ICH triangle:
the Common Technical Document (CTD) is divided into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common to all regions.

 

The Common Technical Document (CTD), as defined by the International Conference on Harmonisation (ICH), covers all information handled in the pharmaceutical industry:

 

• Administrative information, prescribing information and documents specific to each region, for example proposed labels (Module 1)
• Non-clinical and clinical information (Module 2)
• Quality control, manufacturing and chemical information (Module 3)
• Non-clinical study reports (Module 4)
• Clinical study reports (Module 5)

 

Each module demands specific and wide-ranging knowledge. For example, non-clinical and clinical documentation require experience in medicine and other scientific fields, whereas manufacturing and quality dossiers contain technical vocabulary which calls for proficiency in laboratory techniques.