What are Stringent Regulatory Authorities (SRAs)?

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Stringent Regulatory Authorities (SRAs) are national drug Regulatory bodies listed and recognized by the World health Organization (WHO), who are responsible for applying rigorous standards when reviewing and approving drugs/vaccines. The stringent standards set by SRAs focus on the following three (03) key aspects:

Quality: SRAs ensure that drugs are manufactured according to established quality control procedures to guarantee their purity, potency, and consistency.
Safety: SRAs mandate extensive clinical trials to assess potential risks and side effects of new drugs before they are marketed.
Efficacy: SRAs meticulously evaluate the data demonstrating a drug’s efficacy in treating the intended condition(s).

How are SRAs Identified?

SRAs are identified based on two (02) main criteria, which are:

Membership in the International Council for Harmonisation (ICH): The ICH brings together Regulatory authorities from the European Union (EU), United States (US), and Japan to establish a unified approach for pharmaceutical development and registration.
WHO Designation: The WHO maintains a list of SRAs, based on their evaluation of the particular authority’s procedures and adherence to international quality standards.

The Importance of SRAs in the Pharmaceutical Industry

SRAs play a critical role in the pharmaceutical industry, as their regulations help:

Minimize Health Risks: Rigorous testing procedures adopted by SRAs reduce the chances of unsafe or ineffective products reaching the market.
Promote Innovation: Clear, consistent regulations set by SRAs provide a framework for pharmaceutical companies to develop new and effective treatments.
Facilitating Global Access: Approval by an SRA can streamline the process for a drug to be marketed in other countries with similar Regulatory requirements.

Thus, SRAs are essential for building a pharmaceutical landscape that prioritizes patient safety while fostering innovation. Speak to our expert today to learn how Freyr can help you seamlessly navigate the realm of SRAs.

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

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How are SRAs Identified?

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