Dr. Ali Al-Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), held a press conference today at the headquarters of the EDA, in the presence of the Authority's leaders, to review the most important achievements and projects of the Authority during the coming period, as well as to listen to the media representatives and answer their inquiries.
At the beginning of the meeting, the Chairman of the EDA expressed his happiness in communicating with the media representatives, and stressed the importance of periodic meetings with them, praising the role of the media and the EDA's keenness to achieve a real partnership with the media, praising the role of the media in confronting rumors, and that the goal is to deliver the correct information to the citizen.
The Chairman of the EDA explained that the past year witnessed great difficulties and challenges faced by the pharmaceutical market due to the lack of availability of hard currency, which resulted in the unavailability of many preparations in the market, and confirmed that the state has overcome these problems by 97 to 98 % of the shortages, and that it is currently within the normal and safe limits recognized globally and subject to market and manufacturing mechanisms.
He pointed out that the directives of the political leadership are to work on the existence of a strategic reserve of raw materials for the most in-demand pharmaceutical products locally, and that the natural reserve is within the limits of 3 months, and that the Egyptian state is currently working to reach a reserve sufficient for 6 months, and that the Egyptian pharmaceutical market is strong and huge, and the volume of its sales amounted to 307 billion pounds during the past year, compared to sales of 216 billion pounds in 2023, and what was traded last year was 3.5 billion packages, compared to 3.7 billion packages in 2023, and we export to 147 countries.
The World Health Organization (WHO) accreditation obtained by the Authority contributes to developing the strength of Egyptian factories and their ability to compete internationally, and to raise the reputation of Egyptian pharmaceutical products, and increase exports to countries and international organizations working in the humanitarian field.
The Chairman of the Authority stressed that the regulatory process is not limited to good manufacturing practices only, but also extends to good storage and distribution practices, and that the EDA's decisions are made in consultation and dialogue with all concerned parties within the Egyptian pharmaceutical system.
During the conference, the Chairman of the EDA stressed the importance of developing the registration system in the EDA to the electronic system eCTD, which is scheduled to begin working in its first phase at the beginning of April 2025, and that the Authority has contracted with a leading international company in the field of applying this system in more than 75 developed countries in the field of medicine around the world.
He pointed out that several technical meetings were held between the relevant departments within the EDA and the company implementing the project to discuss the application requirements that must be available in the eCTD, and to review the latest developments in preparation for the launch of the project and the availability of submission for the companies.
The Chairman of the Authority explained that there is a great development at the level of the organizational efforts related to registration, with regard to the time required for registration or even the required procedures, and at the level of pharmaceutical preparations, and with the application of the CTD system, this will give us a great additional advantage, as we succeeded during 2024 in issuing:
809 new registration licenses for human pharmaceutical preparations,
347 new registration licenses for veterinary preparations,
About 85 new registration licenses for disinfectants and insecticides,
6753 new registration listing for cosmetic preparations,
121 new registration licenses for herbal and complementary preparations, with a total of 8115 new registration licenses,
Issuance of 5575 trading certificates, listing 84 raw materials.
And that this integrated digital system eCTD speeds up and unifies the procedures for registering preparations, and results in a qualitative leap in their availability in the Egyptian pharmaceutical market, as well as supporting the process of exporting preparations and opening new markets for producing companies, which makes Egypt among the advanced countries in regulating the pharmaceutical industry.
He stressed the EDA's keenness to always extend bridges of communication with industry partners, and the continuous work to improve the services provided by the EDA, and that training programs are being conducted to explain the most important updates related to the registration of human preparations to ensure the continuity of work with the requirements of the WHO and a survey was also announced through the EDA’s official website regarding the implementation of the e-CTD system for registration of human pharmaceutical preparations.
He added that the pharmaceutical tracking and tracing project will enhance the EDA's ability to monitor the Egyptian pharmaceutical market and ensure the quality and effectiveness of pharmaceutical products in accordance with international standards, and lessen expired pharmaceutical products, which supports its presence on the international scene, and that in December 2023, the ""Dwana"" project for tracking narcotic drugs and psychotropic substances was launched, which is part of the ambitious national vision to implement the pharmaceutical tracking project at the republic
In the second half of this year, the tracking and tracing system will be implemented for the most important pharmaceutical preparations that must be strictly controlled, and what will help in this is the readiness of most companies and the current role of the EDA in raising the level of technical requirements applied in stores, warehouses and pharmacies to integrate pharmaceutical supply and distribution chains.
The EDA is playing a very important role in controlling the market, as we succeeded in 2024 in conducting 115 thousand inspection visits, which resulted in the seizure of 15,000 violations, including 592 violations of compulsory pricing, where the value of the seized items reached 271 million pounds, in addition to seizing 216 electronic crimes and issuing 58 publications of seizure from commercial fraud and withdrawal.
Also, 441 violations were issued regarding promotional materials circulating in the pharmaceutical market since the beginning of this year, and 488 reports were received about violating or inappropriate promotional materials, in order to ensure that correct, reliable, up-to-date and non-misleading information is delivered to citizens in an acceptable and appropriate manner for all segments of society.
He praised the strength of the Egyptian pharmaceutical market, and that exports are made to more than 147 countries during 2024, headed by Saudi Arabia and then Spain, while Germany is one of the highest importing countries of Egyptian medical devices during 2024.
The technical operating license was issued for a total of 46 factories for human, herbal, veterinary, disinfectant, biological, cosmetic preparations and medical devices, with a total of 123 production lines for 2024, including 32 medical devices factories exclusively this year, which confirms the great confidence and capabilities enjoyed by the Egyptian pharmaceutical sector. 9630registration licenses were also registered for human, biological, veterinary pharmaceutical preparations, disinfectants, insecticides, cosmetics, herbal, complementary and medical supplies from the EDA.
More than 16,000 inspection visits to factories for human, herbal, veterinary preparations, disinfectants, biological preparations, cosmetic preparations and medical devices, and issuance of 1237 good manufacturing practice certificates.
115,000 inspection visits were carried out, with a value of seizures of 271 million pounds, with the application of the horizontal distribution system to ensure their arrival to all pharmacies in the Republic, and support for the Holding Company for Pharmaceutical Products to develop 48 production lines and increase 50% in the number of studies submitted to its subsidiaries from the reference laboratory.
He also pointed to the increase in the percentage of completed files based on risk assessment in 2024 by 202%, compared to 2023, and the export of analysis results for post market control samples, which reached 678 batches, which would rationalize analysis requirements and optimal use of resources and maintain the effective role of the EDA to ensure the quality, safety and effectiveness of the pharmaceutical products in the Egyptian market, and to deal with 214,516 inquiries and complaints with a completion rate of over 99% to date, and the Center for Continuous Professional Development provided 112 programs with a total of 4189 trainees, and technical and procedural support was also provided to increase the number of preparations that were localized from the previous year to reach 50 preparations with various concentrations, and they were actually traded during 2024, which provides an import bill for their original preparations worth nearly more than 182 million dollars annually, taking into account the needs of the Egyptian patient and providing rare preparations and localizing their manufacture.
In conclusion, the Chairman of the EDA affirmed the continuous communication with all parties of the pharmaceutical system in Egypt, and a full understanding of the objections. We stand by the serious warehouses and support them, and we overcome all obstacles and challenges before them in achieving this, and work in accordance with international standards through which we aim to place Egypt in the position it deserves on the global pharmaceutical map, with the guidance and full support of the political leadership. This requires us to set controls and make decisions that ensure strict control over all aspects of the manufacturing process, starting from the import of raw materials, through the manufacturing, distribution, storage and even sale to the patient, which ensures the availability of safe, effective and high-quality medicine, which is the main goal of the EDA.