Last week the Saudi Arabia Food and Drug General Authority notified manufacturers about the presentation of risk assessment studies for nitrosamines impurities in pharmaceutical preparations.
السادة مدراء المكاتب العلمية المحترمون
السادة وكلاء شركات الأدوية المحترمون
السلام عليكم ورحمة الله وبركاته،،،
انطلاقاً من دور الهيئة العامة للغذاء والدواء الرقابي وحرصاً منها على حماية الصحة العامة وضمان سلامة وجودة المستحضرات الصيدلانية، واستكمالاً للإجراءات التي تقوم بها الهيئة للتأكد من نسبة شوائب النيتروزامين في المستحضرات الصيدلانية.
عليه تؤكد الهيئة العامة للغذاء والدواء بضرورة الالتزام بتقديم دراسات تقييم المخاطر لشوائب النيتروزامين في المستحضرات الصيدلانية المبتكرة والجنيسة (Nitrosamine risk assessment) في التقديم الأولي لتسجيل المستحضرات على أن يتم تحديث جميع أجزاء ملف المستحضر المقدم للتسجيل وإضافة جميع دراسات تقييم المخاطر لشوائب النيتروزامين في الأجزاء التالية من ملف التسجيل:
• الجزء المخصص للشوائب في المادة الصيدلانية الفعالة (Section 3.2.S.3.2)
• الجزء المخصص للشوائب في المنتج النهائي (Section 3.2.P.5.5)
وتقبلوا وافر التحية و التقدير،،،
Thanks google translation!!
Based on the supervisory role of the Food and Drug General Authority and its keenness to protect public health and ensure the safety and quality of pharmaceutical preparations, and to complement the procedures carried out by the Authority to ensure the percentage of nitrosamine impurities in pharmaceutical preparations.
Accordingly, the Food and Drug Authority confirms the need to commit to providing risk assessment studies for nitrosamine impurities in innovative and generic pharmaceutical preparations in the initial submission for registration of the preparations, provided that all parts of the product file submitted for registration are updated and all risk assessment studies for nitrosamine impurities are added in the following parts of the registration file:
The part designated for impurities in the active pharmaceutical substance (Section 3.2.S.3.2)
The part designated for impurities in the final product (Section 3.2.P.5.5)
Does anybody have any experience with Saudi Arabia HA with regards to Nitrosamine topic?
I’ve got information that they’re considering and referring to the EU guideline. No “local” guideline complementing the US/EU/CA guidelines is available to my knowledge.
Has there been further explanations or guidance from SFDA, I couldn’t find anything on the website?
Do we know where they stand with regards to things like EAT, CPCA, LTL?
Or is it rather concepts like the 10% rule and 18 ng/day as lowest AI that they are borrowing from the EU guidance, like some other regulators are still doing?
Dear respected directors of scientific offices and
esteemed representatives of pharmaceutical companies,
peace be upon you and the mercy and blessings of Allah.
Based on the role of the Saudi Food and Drug Authority in
regulatory oversight and its commitment to protecting public
health and ensuring the safety and quality of pharmaceutical
products, and as part of the measures taken by the Authority
to verify the presence of nitrosamine impurities in
pharmaceutical products, the Authority emphasizes the
necessity of submitting risk assessment studies for
nitrosamine impurities in innovative and generic
pharmaceutical products (Nitrosamine risk assessment) in the initial application for product registration. It is required to
update all sections of the product dossier submitted for
registration and add all risk assessment studies for
nitrosamine impurities in the following sections of the
registration dossier:
The section dedicated to impurities in the active
pharmaceutical ingredient (Section 3.2.S.3.2)
The section dedicated to impurities in the finished product
(Section 3.2.P.5.5)
Accept our sincere greetings and appreciation.
