A U.S. based pharmaceutical client approached Freyr for the submission of withdrawal of ANDA to the USFDA and payment of facility fee as per Generic Drug User Fee Amendments (GDUFA).
Read this case to know how Freyr carried the entire process.
Aspect | USA | EU | Australia | China | UAE |
Regulatory Authority | FDA | EFSA & Member State Authorities | FSANZ | SAMR & NHC | ESMA & MOHAP |
Major Regulation Governing Compliance | Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices) | Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers | Food Standards Code (Australia New Zealand Food Standards Code) | Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety | UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food) |
Pre-market Approval Required? | No pre-market approval except for novel ingredients, color additives, or specific claims | No pre-market approval for general foods, but novel foods or health claims require EFSA approval. | No pre-market approval unless it's a novel food or makes health claims | Pre-market registration is required for novel foods, health foods, or products with new ingredients | Pre-market approval is required for certain foods, health products, and products with new ingredients |
Processed Food Labeling Compliance /Labeling Requirements | Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens) | Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling. | Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required | Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life | Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required |
Timeline for Registration | No fixed timeline: products can enter the market once compliant | No formal registration unless novel food; EFSA approval for health claims takes 12-18 months | No formal registration unless it's a novel food or makes health claims | Typically, 12-24 months for novel foods, shorter for regular processed foods | Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained |
A U.S. based pharmaceutical client approached Freyr for the submission of withdrawal of ANDA to the USFDA and payment of facility fee as per Generic Drug User Fee Amendments (GDUFA).
Read this case to know how Freyr carried the entire process.