Within the framework of continuous meetings organized by the SFDA (represented by its Drug sector) with related authorities, the first meeting with officials in ministries concerned with duties of monitoring and registering human and veterinary drugs has been held.
At the beginning of the meeting, His Excellency, d. Saleh bin Abdullah Bawazeer, the Vice President of Drug Affairs, welcomed the attendants and thanked the participants whom are: Mr. Aziz Dayoob, one of the European Union specialists and one of the sector consultants in field of information technology, Mr. Holiger Spalt and Mr. Andres Chochenk, the representatives of EXTEDO Company which apply the program of electronic registration for European central registration that is implemented by most of European Union Countries. After that, his Excellency explained several aspects that are:
- The importance of the electronic registration program and its benefits to the SFDA or the applicants as well as (the companies that aim to register).
- The significance of having one unified program for the Kingdom, Gulf Countries as well as Arabian ones conforms completely to the World Registration Program, which is implemented in several modern countries especially European ones that have experiences in this field, to insure having no differences in electronic registering files submitted by the companies.
- The mechanism of transferring from the old program that is applied recently to the new electronic one will have several gradual stages during which drug registration process will continue.
- The users of the program should be aware of how to present and modify the electronic file if needed.
After that, Mr. Aziz talked about the elements of the electronic file that has five components, the advantages and requirements of electronic registration system and some of incorrect actions done by drug companies during the electronic presenting.
Then, Mr. Holiger, the representative of EXTEDO Company, delivered a speech about the mechanism that is implemented in presenting the application electronically and its track since its submission till the issuance of the last report by the authority which evaluates the application. Next, he referred to the mechanism used in European Union Countries EMEA and he made a trail registration application in order to help attendants comprehend the system perfectly.
In addition, Mr. Andres from EXTEDO Company shed lights on electronic registration and provided examples about European Countries experiences. Also he mentioned the effect of using the electronic registration as well as its role in minimizing the difficulties of dealing with paper files and how it results in saving time during the process of drugs registering.
At the end of the meeting, d. Saleh Bawazeer, the Vice President of Drug Affairs, gave the opportunity to attendants to ask and lecturers answered their questions.
In the meeting, several authorities participated like : 1- the Ministry of health - represented by the department of drugs registration in the General Administration of Medical and pharmaceutical licenses and the scientific committees as the preparation committee, committee of pharmaceutical products registration, and the main registration committee 2- the Ministry of Agriculture - represented by the department of veterinary drug registration in the General Administration of Animal Resources 3- the working group of veterinary drugs registration in the drug sector as well as the employees of SFDA drug sector and the number of attendants was 48 participants.
It worth mentioning that the SFDA represented by the drug sector, had held alike meeting with the private sector as well as local and foreign drugs companies to discuss the (Common Technical Document CTD) and the requirements of electronic registration.