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eCTD mandatory?

After more than a decade of hesitation, the HMA (EMA) made the decision:
By 2017-2018, in all European registration procedures eCTD-based work will be made mandatory.
Although the development and introduction of eCTD began at the end of the 1990s, and it was already clear for every skilled person that this was the future, yet two decades were necessary to make it compulsory by the European authorities.

The main reasons for this were probably:

  • Fear of introducing the "new" system (of course it was just a new form, the content was not).
  • The appropriate specialists were missing (?)
  • The introduction had financial consequences.

It is obvious that none of the problems were justified, and its use is general, and therefore the authorities undertook to make the publication of the eCTD mandatory in all the procedures, which is beneficial for both the pharmaceutical companies and for the licensing authorities.

Deadlines:

The time is pressing for the full introduction, because the HMA (EMA) gave quite tight deadlines:


The eCTD format becomes/will become mandatory :

Types of authorization procedure

currently mandatory

Central registrations

From 2015

new DCP registration procedures

January 01, 2017

new MRP registration procedures

January 01, 2018

for all registration, modification, renewal procedures in case of MRP/DCP

July 01, 2018

for the new registration processese

January 01, 2019

in case of all national procedures (renewal, variation, PSUR, etc.)

The following options are available for a previously registered drug:

  • preparation of an eCTD documentation without a so-called Baseline documentation:

If the compilation (or renovation) of a variation is necessary, than a 0000 sequence is prepared instead of the previously authorized documentation, which includes only a few basic data, and the new variation (or renovation) is built on this as 0001 sequence.

  • Preparation of eCTD documentation with so-called Baseline documentation:

The 0000 sequence is prepared with the currently accepted full Module 1 (Administrative data) and Module 3 (Quality) documentations, the next variation (or renewal) will be built on this as the 0001 sequence. In case of the Baseline documentation the minimum requirement is the existence of Module 1 and Module 3 files.

  • Preparation of a complete eCTD documentation:

a 0000 sequence is prepared starting from the Baseline documentation, and all variations, renewals will be built on it as additional sequences.
In case of preparing a complete eCTD documentation all data previously accepted by the authority can be retrieved, and the necessary information can be found easily in a few seconds, with a few keypress.

The role of Pro-Pharma '93 Pharmaceutical Consulting Institute in the complete changeover:

Pro-Pharma’93 Pharmaceutical Consulting Institute was established in 1993 in Budapest, Hungary with the aim of conducting expert activities in the whole field of drug development and licensing in Europe. One of its main areas is registration, including life-cycle tracking, and renewals for already registered products too. (Medicines, Medical Devices, Dietary Supplements and Nutrition).
The ELECDOC Electronic Pharmaceutical Files Ltd. was founded by the Pro-Pharma ’93 Pharmaceutical Consulting Institute in 1998 with the aim of prepare documentations on eCTD basis among the first in Europe (later on, by the request of its partners NeeS files were also compiled which was a mistake by the authorities and slowed down the introduction of the truly usable eCTD).
This activity melted into Pro-Pharma's extensive registration work in 2006 and produced well over one hundred eCTD dossiers (not including NeeS files) in all categories and with complete life cycle tracking.

Pro-Pharma specialists undertake:

- compilation of complete, new registration documentations (Module 1-5), and preparation in  eCTD format

- with a drug already registered on a paper basis preparation of the currently required renewal and modification documentation, on demand together with the eCTD documentation from the baseline or the complete registration files

- with a drug already registered on NeeS basis, preparation of the currently required renewal and modification documentation, on demand with the transformation of the complete NeeS registration documentations to eCTD format  
Benefits of the order:

- not just an IT specialist is carrying out the work, but a team whose members are also reviewing the documentation from a registration point of view

- you do not have to buy your own program, our company has an up-to-date eCTD manager program

- we have modern computing backgrounds and utilities (for example Adobe Acrobat Professional  and modern operating system) for the preparation of high-quality eCTD documentation,  which are essential for the preparation of the eCTD documentation

- we are able to provide our clients with a short deadline for all types of eCTD material

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Pro-Pharma ’93 Gyógyszeripari Tanácsadó Intézet Kft.
1144 Budapest, Füredi utca 34.
Tel.: 06-1-231-8060
e-mail: company@propharma.hu
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