Steps to Register New Pharmaceuticals

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The FDA Approval Process
Exemptions from FDA Approval
Good Manufacturing Practice
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Once a new medicine has been formulated, there are stringent guidelines to ensure that it is safe for public consumption. The manufacturer will need to perform clinical trials to test its efficacy. Thereafter, it must be registered and approved by the FDA. Here’s what you need to know as a manufacturer of pharmaceuticals.

The FDA Approval Process

The manufacturer needs to make three separate submissions to the FDA (The Food and Drug Administration). The first step is to register the company for drug manufacturing. Secondly, a labeler code is required. Finally, the product must be listed. These submissions can be sent to the FDA via electronic submission gateway (ESG).

Once a drug has been tested, the business submits a new drug application (NDA). Their application must provide results of clinical tests, the manufacturing process, labels, uses risks, and how to take the drug. The FDA has scientists and doctors who review the NDA. They need to make sure that the company can produce a quality product and that the benefits outweigh the risks.

Although the FDA doesn’t actually test drugs, it follows up after approval and inspects the premises where the medicine will be manufactured.

Exemptions from FDA Approval

Pharmacies that adhere to regulations and are engaged in filling prescriptions don’t need to apply for FDA approval, provided they are not involved in the manufacture of drugs and do not repack or label them differently. The same conditions apply to health care institutions such as clinics and hospitals. Licensed doctors whose use of drugs is only in their private practice and drug distributors are also exempt.

If drugs are housed in a storage facility but not manufactured, they do not require approval. Similarly, companies that produce inactive ingredients that combine with pharmaceuticals are excluded. Lastly, when drugs are used for research, chemical analysis, or teaching purposes, the institutions involved do not need approval.

Good Manufacturing Practice

Good manufacturing practice (GMP), as it relates to pharmaceuticals, is needed to make sure that these drugs comply with quality standards and are produced uniformly. GMP minimizes any further risks associated with a product. These risk factors include product contamination, wrongly labeled packages, and incorrect amounts of the active ingredient. These potential problems could result in excessive or ineffective outcomes, giving a patient a different medication from what has been prescribed, or health issues, even death.

GMP assesses every aspect of the manufacturing process. This involves making sure the right raw materials are used, equipment is in good working order, and premises and staff meet hygiene standards. Each process must be recorded in writing. Documentation must be maintained for every stage of manufacturing.

The World Health Organization (WHO) has provided countries with step-by-step guidelines to cover GMP for pharmaceuticals. Companies are advised to get GMP Certified, as this will satisfy the FDA that they are compliant. A receiving country will only import medicines that meet GMP standards and will only sell those that have been produced at home if they are certified.

When producing new medicines for public consumption, manufacturers need to exercise due caution, follow the FDA process of registration, and get GMP audited.