EU: How to Obtain a New Drug Marketing Authorisation.

The European Medicines Agency (EMA) evaluates and controls marketing authorisation applications in the European Union. The authorisation procedure enables pharmaceutical companies to submit a single application to the agency in order to conduct marketing activities and make the product available to healthcare providers and patients throughout the European Economic Area.

Steps in the procedure include: 

1. Submission of eligibility request 7-18 months before submission of marketing authorisation application.
2. Notification of intention to submit an application seven months before submission of marketing authorisation application.
3. Appointment of rapporteurs by the Committee for Medicinal Products for Human Use (CHMP). In addition, the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to conduct scientific assessments.
4. Pre-submission meetings where the applicants obtain regulatory and procedural advice from the EMA. This step is optional, but recommended because it can help applicants submit applications that conform to legal and regulatory requirements. 

Pre-submission meetings generally speed up the validation process. This step is typically undertaken 6-7 months before submitting the marketing authorization application. 

5. Re-confirmation of communicated submission date initially submitted to the EMA, 2-3 months before submission of marketing authorisation application.

Approval Process for Generic Drugs.

Generic drugs are copies of a branded drug developed by another company once patents and rights have expired. They typically cost less than branded drugs, however they must undergo an approval process by the FDA and EMA before distribution. 

The approval process for generic drugs in the United States usually must demonstrate that: 

• All patents or legal exclusivities pertaining to the branded drug have expired
• The generic drug and branded drug are “pharmaceutically equivalent”
• The manufacturer adequately produces the medicine according to regulations and standards
• Production of the drug is consistent
• The active pharmaceutical ingredient or API of the drug is equivalent to the one used in the branded drug
• The right amount of API gets to the targeted location in the body for the intended effect
• Any inactive ingredients in the drug are safe for human consumption
• The medicine does not break down or decompose over time
• The label of the generic drug is the same as the label used by the branded drug
• Any containers used for shipping and selling the drug are appropriate

United States: The NDA and Drug Development Process.

The New Drug Application (NDA) process has governed the control of new drug development in the United States since 1938. During the procedure, drug sponsors formally propose approval by the FDA using data obtained during human clinical trials and animal studies. 

The NDA is part of the full drug development process with steps that include:

1. Discovery and Development
2. Preclinical Research
3. Clinical Research
4. FDA Review
5. FDA Post-Market Safety Monitoring

The goals of the NDA procedure are as follows: 

• To determine if the drug is safe and effective for its proposed use(s)
• If the benefits of the drug outweigh the patient’s risks
• Whether the drug’s proposed labeling and package insert is sufficient, and what information it should contain
• If manufacturing methods and quality controls are sufficient to maintain the drug’s identity, strength, purity, and quality

Why Buy GMP-Certified Products?

GMP-certified products are produced and controlled according to standards set by regulatory authorities and relevant industry organizations.