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 |
| Aspect | USA | EU | Australia | China | India |
|---|---|---|---|---|---|
| Regulatory Authority | FDA (U.S. Food and Drug Administration) | EFSA (European Food Safety Authority) & European Commission | FSANZ (Food Standards Australia New Zealand) | SAMR (State Administration for Market Regulation) | FSSAI (Food Safety and Standards Authority of India) |
| Major Regulation Governing Compliance | 21 CFR Part 106 & 107 – Infant Formula Regulations | Regulation (EU) No 609/2013 on Foods for Specific Groups (FSG) | Australia New Zealand Food Standards Code | GB Standards (e.g., GB 10765-2021) for infant formula | Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019 |
| Pre-market Approval Required? | Yes – Manufacturer registration and notification | Yes – Pre-market notification and composition review | No – Comply with standards, but no pre-approval | Yes – Mandatory registration with SAMR | Yes – Prior approval and product registration required |
| Labeling Requirements | Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula. | Must comply with harmonized EU labeling rules, including allergens, nutrition info | Must comply with FSANZ labeling codes | Must follow GB labeling standards, including mandatory warnings | Must follow specific infant food labeling rules under FSSAI |
| Nutritional Composition Requirements | Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required | Detailed compositional criteria for energy, protein, vitamins, and minerals | Must meet nutrition content standards specified by FSANZ | Stringent GB compositional standards; new updates in 2021 | As per Schedules under FSSAI regulations, modeled on Codex guidelines |
| Claims Allowed | Limited; FDA approval required for structure-function or health claims | Only EU-authorized claims permitted; No health or nutritional claims on infant formula | Functional and nutrient claims allowed within Regulatory limits | Strict control; health/nutritional claims require SAMR review | Only pre-approved nutrition claims allowed; therapeutic claims not permitted |
| Clinical Evidence Required? | Yes – Especially for new formulations or ingredients | Yes – EFSA scientific dossier for novel ingredients or composition | Required for novel ingredients or changes in nutrient bioavailability | Yes – For new products or ingredient combinations | Yes – If deviating from standard composition or for novel formulations |
| Timeline for Registration | ~6–12 months, depending on product review | ~12–18 months, including EFSA evaluation | ~3–6 months for market entry if compliant | ~18–24 months, including safety and technical review | ~12–18 months for full Regulatory clearance |
| Need for Local Representative | Yes | Yes | No | Yes | Yes |
Aspect | USA | EU | Australia | India | UAE |
| Regulatory Authority | FDA Center for Tobacco Products (CTP) / CDER | EC / Member States | TGA / FSANZ | Ministry of Health and Family Welfare and National Tobacco Control Cell (NTCC) | ESMA / MOHAP |
| Major Regulation Governing Compliance | Family Smoking Prevention and Tobacco Control Act (TCA); | Tobacco Products Directive 2014/40/EU (TPD); Novel Food Regulation | Therapeutic Goods Act 1989; Tobacco and Nicotine legislation; (Therapeutic Goods Standards for Nicotine and Therapeutic Vaping Products – TGO 110) | Food Safety and Standards Act (COTPA, 2003 and 2023 Amendment Rules; Prohibition of Electronic Cigarettes Act, 2019) | UAE Federal Law No. 15 (Tobacco Control); ESMA standards |
| Pre-market Approval Required? | Yes [Pre-market Tobacco Product Application (PMTA) for vaping products; drug approvals for nicotine gum) | Yes (Novel Food approval for some products; TPD notification for tobacco products) | Yes (Therapeutic Goods Administration approval) | Conventional tobacco products – not subject to registration; Nicotine products – approval required from Drug Authorities; Vapes/e-cigarettes – not applicable | Yes (Registration and conformity assessment required) |
| Labeling Requirements | FDA labeling rules for tobacco and nicotine products, including warnings | EU TPD labeling requirements, health warnings | TGA labeling for therapeutic/tobacco products | Labeling requirements as per MoHFW, including warnings and prescribed content | Mandatory health warnings and labeling per ESMA/MOHAP |
| Timeline for Registration | 12-24 months (PMTA review can be lengthy) | 6-18 months, depending on product and approval | 6-12 months depending on product class | Traditional tobacco – no registration pathway; Other nicotine categories – as applicable | 6-12 months registration and approval |
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.
