First Pharmaceutical Submissions in eCTD Format registered at Medicines Control Council of South Africa

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In course of its reviewing and validation project MCC has validated two eCTD submissions using EXTEDO’s reviewing and validation tool

We are thrilled that by implementing our Validation und Reviewing System we have been able to make a contribution to MCC’s efforts to bring medicines to the South African people faster

EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that the Medicines Control Council (MCC) of South Africa has successfully used EXTEDO’s reviewing and validation tool for registering pharmaceutical submissions prepared in eCTD format for the first time ever.

The successful registrations of an NCE (new chemical entity) and a generic drug mark an important milestone in MCC’s efforts to introduce the eCTD standard to South Africa. Currently the medicines approval process in African countries can take as long as three years and the delays deny timely access of essential medicines to the sick. South Africa is committed to dramatically reduce registration times and in 2013 MCC launched its reviewing and validation project. Hence, South Africa is the first African country to start a time-effective reviewing process and accept electronic submissions instead of paper-based submissions.

To enable the processing of electronic submissions MCC selected an EXTEDO solution based on EURS (EXTEDO Universal Reviewing System) to validate, import, and review electronic submission information sent by pharmaceutical companies on electronic media. EURS is in use at the European Medicines Agency and many other European regulatory authorities. For implementation in South Africa, regional requirements of MCC have been jointly worked out and have been adopted within the solution.

“We are thrilled that the project has been such a great success so far and that by implementing our Validation und Reviewing System we have been able to make a contribution to MCC’s efforts to bring medicines to the South African people faster,” said Martin Schmid, CEO for EXTEDO. “We are very much looking forward to continuing the mutually pleasant and productive collaboration in this pilot project.”

“Furthermore,” Schmid added, “besides the cooperation with MCC, our industry customer base is constantly growing and we are especially delighted that the first eCTD submission of a generic medicine to be registered in South Africa has been prepared using our eCTDmanager solution”.
EXTEDO supports the South African pharmaceutical industry by providing eCTDmanager, a submission management and publishing tool. A number of industry customers have already started using eCTDmanager for creating eCTD, NeeS, and paper based submissions.

About EURS
EURS (EXTEDO Universal Review System, formerly called EURS is Yours) is a multifunctional software solution that serves as an overall eCTD validation and reviewing software tool. It reports whether a submitted eCTD- or NeeS-based application conforms to the official eCTD format. It is especially designed for the validation, acceptance, import, review and maintenance requirements of the EMA (European Medicines Agency), the associated national competent authorities (NCAs), and also of authorities outside of the European Union, e.g. the Saudi FDA or the Swissmedic.

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). EXTEDO’s focus is on optimizing clients’ eRegulatory business processes. The company’s enabling technology, the EXTEDOsuite, is unique in that it covers the complete regulatory landscape including: product registration planning & tracking (IDMP), submission publishing & lifecycle management, pharmacovigilance management and document management. Today, EXTEDO serves over 700 customers in 60 countries, including the EMA and more than 25 regulatory authorities worldwide.

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Daniela Miltner
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