Egyptian Drug Authority

Workshop on process of Marketing Material File Submission. The Egyptian Drug Authority (#EDA) is pleased to announce the opening of registration for the Workshop on process of marketing material file submission. This training program aims to train representatives of pharmaceutical companies and scientific offices with the regulatory guidelines for submitting files related to promotional, educational, and awareness materials. The training program is scheduled to take place on Thursday, July 31, 2025, at EDA Premise, Maadi. The program is intended for representatives of pharmaceutical companies, scientific offices, and advertising agencies. The training program will start from 9:30 AM to 3:30 PM The deadline for registration on Tuesday, July 29, 2025. To register, please click on the following link: https://lnkd.in/d-GB6ZHn To view the agenda, please click on the following link: https://lnkd.in/d8w2nurk The trainee will receive a certificate of attendance accredited by the Egyptian Drug Authority Center for Continuing Professional Development. #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

تأكيدًا لريادتها الإقليمية وحرصها على تعزيز التعاون الدولي لضمان جودة وسلامة المستحضرات هيئة الدواء المصرية تشارك في الاجتماع السنوي لمنظمة التعاون الدولي لتنظيم مستحضرات التجميل بكندا ……… أعلنت هيئة الدواء المصرية، عن انتهاء مشاركتها في أعمال الاجتماع السنوي للدورة التاسعة عشرة لمنظمة التعاون الدولي في تنظيم مستحضرات التجميل (ICCR-19)، والذي عُقد في كندا ، بحضور أعضاء اللجنة التوجيهية من دول بارزة تشمل البرازيل، كندا، الاتحاد الأوروبي، الولايات المتحدة الأمريكية، كوريا، اليابان، وتايوان، إلى جانب مراقبين من المملكة العربية السعودية، تايلاند، المملكة المتحدة، الصين، والرأس الأخضر. مثل الهيئة في الاجتماع، الدكتورة هبة عصام الدين، مدير عام الإدارة العامة لتسجيل مستحضرات التجميل، الدكتورة سندس محمد السعيد، مدير إدارة التعاون مع المنظمات الدولية بمكتب رئيس الهيئة. تم خلال الاجتماع مناقشة آخر المستجدات الرقابية بين الدول الأعضاء، وآليات تطوير عمل المنظمة خلال المرحلة المقبلة، بالإضافة إلى استعراض نتائج مجموعات العمل التي يشارك فيها خبراء الهيئة، والتي تركز على تقييم سلامة مكوّنات مستحضرات التجميل، وتعزيز التواصل مع المستهلك، وتطوير التعليمات الإلكترونية (e-labelling). كما شاركت الهيئة في مناقشات موسعة مع ممثلي الصناعة والمنظمات المختلفة حول تطبيق مناهج تقييم المخاطر من الجيل التالي (Next Generation Risk Assessments - NGRA). وأعلنت اللجنة الدائمة للمنظمة بمناسبة مرور عشرين عامًا على تأسيسها عن إنشاء فريق عمل مشترك جديد لمراجعة الأهداف الحالية ودراسة التوجهات المستقبلية للمنظمة. يأتي ذلك في إطار استراتيجية هيئة الدواء المصرية لتعزيز حضورها الدولي، وتبنّي أفضل الممارسات العالمية في تنظيم ورقابة مستحضرات التجميل والمنتجات الصحية، كما تعكس التزام الهيئة بدعم تبادل الخبرات الفنية والعلمية مع الهيئات والمنظمات الدولية، بما يُسهم في رفع كفاءة القطاع الدوائي، وتحقيق أعلى معايير الجودة والسلامة، بما يضمن سلامة وجودة مستحضرات التجميل في مصر وعلى مستوى العالم. #هيئة_الدواء_المصرية #المركز_الإعلامي_لهيئة_الدواء_المصرية #الدواء_المصري

Joint Training Initiative in Cooperation with the Chamber of Pharmaceutical Industry, Medical Supplies, and Cosmetics The #EgyptianDrugAuthority is pleased to announce the launch of the Joint Training Initiative in collaboration with the Chamber of Pharmaceutical Industry, Medical Supplies, and Cosmetics. This initiative includes a training program providing a comprehensive overview of the Common Technical Document (CTD) modules, as well as standards for preparing and submitting CTD files, delivered through successive training rounds. As part of the strategic coordination and collaboration between the Chamber and the Egyptian Drug Authority (EDA), and in alignment with the shared priorities for the year 2025, we are honored to announce the completion of preparations for the Joint Training Initiative for the preparation, review, and submission of CTD registration files. This aims to enhance the capabilities and skills of company teams involved in registration and quality affairs. The training program will provide member companies of the Chamber with structured training on the CTD registration system. The initiative includes the following: ·      The program targets the training of 250 trainees from 50 companies, with 2 trainees from each company (one Regulatory Affairs Manager and one Quality Manager). ·      Each training round will include 50 participants. ·      The training duration is 5 consecutive days, with 6 training hours per day, and in-person attendance is required. ·      The training cost is 5,000 EGP per participant. The Chamber will cover 80% of the total cost, and each company will pay the remaining 20% (EGP 1,000) directly to the EDA upon registration through the program link. ·      Each company is allowed to nominate only 2 trainees. In the event a company wishes to enroll more than two participants, it will bear the full cost (5,000 EGP per trainee) for any additional participant. The first round of the training program was held last April 2025, the second round was held last May 2025, the third round was held last June 2025, and the fourth round scheduled to begin on Sunday, July (27-31). The training program will be repeated in August 2025, at the Egyptian Drug Authority premises in Mansouria. Training Program will run from 9:30 AM to 3:30 PM. The registration deadline is Wednesday, July 23, 2025. All attendees will receive a Certificate of Attendance accredited by the EDA’s Center for Continuing Professional Development. To register, please click the following link: https://lnkd.in/dJ7D7tJp To view the agenda, please click the following link: https://lnkd.in/ddSxHKan #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

In the Context of Developing the Pharmaceutical Sector Regionally and Internationally Head of the Egyptian Drug Authority Meets with Global Company MSD to Enhance Pharmaceutical Security and Explore Localization Opportunities ….. El-Ghamrawy: "We are working diligently to create a flexible regulatory environment that encourages investment and technology transfer." Dr. Ali El-Ghamrawy, Head of the Egyptian Drug Authority, held an official meeting with the global pharmaceutical company MSD, led by Dr. Hazem Abdel Samie, Managing Director of MSD Egypt, and Dr. Yasmine Maher, Director of Regulatory Affairs & Scientific Office Manager. The meeting aligns with the EDA’s ongoing efforts to strengthen cooperation with major international companies and develop Egypt’s pharmaceutical system. Discussions focused on future cooperation areas, including MSD’s performance in Egypt for 2024, mechanisms to facilitate the launch of new products, and opportunities to localize the production of biological medicines, aiming to reduce import costs and enhance pharmaceutical security. Both parties emphasized the importance of adopting flexible regulatory policies that support innovation and address patient needs, especially regarding high-tech imported products. Dr. El-Ghamrawy affirmed that the EDA prioritizes partnerships with leading international companies like MSD to improve the local pharmaceutical industry and boost its competitiveness regionally and globally. He highlighted the Authority’s strategy of supporting the localization of biological and advanced pharmaceutical technologies while maintaining access to innovative medicines without compromising quality or efficacy. He also underscored the importance of continued collaboration to support local manufacturing and technology transfer, address market challenges, and develop innovative solutions that enhance pharmaceutical security and achieve self-sufficiency. MSD representatives praised the EDA’s role in fostering an attractive investment climate and implementing flexible regulatory policies that expedite the registration and distribution of innovative medicines, ultimately contributing to improved healthcare outcomes in Egypt. The meeting was attended by Dr. Osama Hatem, EDA Assistant Chairman for Policy and International Cooperation and Supervisor of the Central Administration for Pharmaceutical Policies and Market Access and Dr. Hossam Abdullah, Assistant Chairman for Market Support and Continuity. This meeting reflects the EDA’s commitment to building strategic partnerships with global pharmaceutical leaders, promoting investment in local manufacturing and scientific research, and enhancing the pharmaceutical product registration and distribution system. These efforts aim to improve healthcare services and ensure sustainable availability of essential medicines for Egyptian patients. #EgyptianDrugAuthority #EgyptianDrugAuthorityMediaCenter #EgyptianPharmaceuticals

Workshop on good laboratory practice in cosmetics quality control laboratories. The Egyptian Drug Authority (#EDA) is pleased to announce the opening of registration for the Workshop on good laboratory practice in cosmetics quality control laboratories. This workshop aims to provide participants with an in-depth understanding of Good Laboratory Practices applied in quality control laboratories for cosmetic products. The workshop is scheduled to take place on Monday, July 21, 2025, at EDA premises, Mansouria. The workshop is intended for representatives of companies. The workshop will start from 9:30 AM to 3:30 PM. The deadline for registration is Thursday, July 17, 2025. To register, please click on the following link: https://lnkd.in/dGkGDkB4 To view the agenda, please click on the following link: https://lnkd.in/dm5kv9dN The trainee will receive a certificate of attendance accredited by the Egyptian Drug Authority Center for Continuing Professional Development. #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

Chairman of the Egyptian Drug Authority Inspects Vitabiotics Egypt and Gelatin Factories in New Borg El Arab City El-Ghamrawy: Continued Support for Localizing Pharmaceutical Industries and Achieving Self-Sufficiency …............... Dr. Ali El-Ghamrawy, Chairman of EDA, conducted a field visit to Vitabiotics Egypt and the Arab Company for Gelatinous and Pharmaceutical Products in New Borg El Arab City, Alexandria. The tour focused on reviewing production capabilities, observing adherence to international quality standards, and encouraging investment in pharmaceutical manufacturing to enhance local capacity. Dr. El-Ghamrawy emphasized the EDA’s ongoing support for national pharmaceutical projects that contribute to self-sufficiency and reduce dependence on imports, in alignment with Egypt's Vision 2030. He commended the efforts of both companies in modernizing production lines and aligning operations with global standards, reaffirming the Authority's commitment to providing technical and regulatory support to strengthen the competitiveness of Egyptian products. Vitabiotics Egypt has developed production lines in its factory in the Borg El Arab area to gradually increase production capacity from 15 million packs to 25 million packs annually by the end of 2025, through key axes including: increasing tablet and capsule production from 132 million to 250 million units annually, raising liquid bottle production from 24 million to 33 million units annually, and increasing strip production to 50 million strips instead of the current 31 million. The Arab Company for Gelatinous and Pharmaceutical Products highlighted its role in enhancing local supply chains, with a production capacity of 2.5 billion hard capsules and 275 million soft capsules annually. The company has invested over EGP 50 million to boost production capabilities, including inhalation anesthetics, veterinary products, and contract manufacturing for 35 companies, achieving 70% growth in 2024 compared to 2023. Representatives from both companies acknowledged the EDA’s pivotal role in supporting local manufacturing and facilitating regulatory processes. They stressed that close collaboration with the Authority is vital for achieving industrial sustainability and enhancing export competitiveness. The visit was attended by senior EDA officials, including Dr. Yasin Ragaey, Dr. Amany Gawdat, Dr. Amira Mahjoub, and Dr. Osama Hatem. It reflects the Authority’s strategy to foster public-private partnerships, promote investment in advanced pharmaceutical production, and localize vital industries that support public health and economic growth. The EDA reaffirms its commitment to collaborating with strategic partners to realize Egypt’s goal of becoming a regional hub for pharmaceutical manufacturing, supporting national health priorities and contributing to long-term pharmaceutical security and self-sufficiency. #EgyptianDrugAuthority #EgyptianDrugAuthorityMediaCenter #EgyptianPharmaceuticals

Training Webinar on (Medication Management for Chronic Coronary Syndrome. The Egyptian Drug Authority (#EDA) is pleased to announce the opening of registration for the training webinar on (Medication Management for Chronic Coronary Syndrome within Unlock the Pharmacist Potential Initiative and Awareness of EDA activities and publications. This training webinar aims to Awareness for Community Pharmacists about Rational Medication Management for Chronic Coronary Syndrome. The training webinar is scheduled to take place on Tuesday, July 22, 2025 at Online Platform. The program is intended for Community Pharmacists. The webinar will start at 12:00 PM and end at 3:00 PM. The deadline for registration is Monday, July 21, 2025. To register, please click on the following link: https://lnkd.in/deGzNmXx To view the agenda, please click on the following link: https://lnkd.in/dH3GDT-T #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

Training program on The Periodic Benefit Risk Evaluation Reports (PBRERs) The Egyptian Drug Authority (#EDA) is pleased to announce the opening of registration for the Training program on The Periodic Benefit Risk Evaluation Reports (PBRERs). This training program aims to provide comprehensive theoretical and practical knowledge on all topics related to the submission of the periodic benefit-risk evaluation report (PBRER) for each pharmaceutical product. It covers the objectives and purpose of the report, how it is prepared, and its submission timeline in accordance with the Good Pharmacovigilance Practice (GVP) guidelines in Egypt. The training program is scheduled to take place on Sunday and Monday, July 27th and 28th, 2025 at EDA Premise Maadi and/or via an online platform. The program is intended for PV staff at pharmaceutical companies. The training program will start from 9:30 AM to 3:00 PM The deadline for registration on Wednesday, July 23, 2025. To register, please click on the following link: https://lnkd.in/dp_sgsBu To view the agenda, please click on the following link: https://lnkd.in/d9xBfTWd The trainee will receive a certificate of attendance accredited by the Egyptian Drug Authority Center for Continuing Professional Development. #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

Training Webinar on (Medication Management for Chronic Coronary Syndrome. The Egyptian Drug Authority (#EDA) is pleased to announce the opening of registration for the training webinar on (Medication Management for Chronic Coronary Syndrome within Unlock the Pharmacist Potential Initiative and Awareness of EDA activities and publications. This training webinar aims to Awareness for Community Pharmacists about Rational Medication Management for Chronic Coronary Syndrome. The training webinar is scheduled to take place on Tuesday, July 22, 2025 at Online Platform. The program is intended for Community Pharmacists. The webinar will start at 12:00 PM and end at 3:00 PM. The deadline for registration is Monday, July 21, 2025. To register, please click on the following link: https://lnkd.in/deGzNmXx To view the agenda, please click on the following link: https://lnkd.in/dH3GDT-T #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

Awareness workshop for Stroke, Interstitial Lung Diseases “ILD and Pharmacovigilance The Egyptian Drug Authority (#EDA) is pleased to announce in collaboration with Boehringer Ingelheim, the opening of registration for an awareness workshop for Stroke, Interstitial Lung Diseases “ILD and Pharmacovigilance. This workshop aims to raise awareness and enhance the role of pharmacists in three critical areas: stroke prevention and early detection, recognition of interstitial lung disease (ILD), and strengthening pharmacovigilance practices. The program is designed to equip pharmacists with the knowledge and tools needed to support early intervention, improve patient outcomes, and ensure medication safety. The workshop is scheduled to be held on Thursday, July 17, 2025, at EDA Premises – Mansoria and/or via an online platform. The workshop is intended for hospital and community pharmacists. The workshop will start from 9:30 AM to 2:30 PM. The deadline for registration is Tuesday, July 15, 2025. To register, please click on the following link: https://lnkd.in/d5Qm8fSn To view the agenda, please click on the following link: https://lnkd.in/dY6G_Pa9 #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals