Reference in Pharmaceuticals

What is difference between Regulation and Guidelines in Pharmaceuticals ?
it’s same OR there is some different ?

Thank you in advance

In broadway, these are the same but you can differentiate these both by understanding that regulation has the compulsion to follow and guidelines are suggestions those you should follow. I think so, someone can add his input.

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Rightly said by Ankur.
The Regulations are mandatory to follow and must comply without any deviations.
Guidelines may be followed as such or we may have an alternative approach that can be followed. However, we must have a scientific explanation to justify that the alternative approach/methodology will be suitable and scientifically sound meeting regulatory requirements.

Guidance documents describe the FDA’s interpretation of their policy on a regulatory issue. These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.
FDA guidance describes the Regulatory agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA/Regulatory authority.
FDA/Regulatory authority develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act or other related laws of that country.

Laws- Laws are passed by the parliament houses of the government and then signed by the authorities.

Regulations- Regulatory Agencies are tasked with implementing laws by drafting regulation. They take the broad ideas of the bill /law passed and fill in the details of what needs to be done and how it will be enforced. Regulation is created by a rule-making process, including a notice of proposed rule-making and a public comment period. Once a final rule is issued, it has the force of law because it is implementing a law.

Rules- While regulations cover a topic broadly, rules get into the nitty-gritty. A regulation may be comprised of many individual rules.

Guidance- Guidance is supplemental material published by an agency that helps clarify existing rules. These include interagency statements, advisories, bulletins, policy statements, questions and answers, and frequently asked questions. It is not subject to rule-making procedures, so there is no proposal or comment period. Guidance can be helpful, but it is not binding.


Thank you for kindly reply
I appreciate it

I appreciate your reply