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New Drug Applications: US and EU Procedures
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New Drug Applications: US and EU Procedures
Developing, testing, and approving a new medication is a rigorous process that requires significant time and investment. Critical to this process is the New Drug Application (NDA) in the United States or the Marketing Authorisation Application (MAA) in the European Union. This quick guide explores the critical components of new drug applications and procedures in the European Union and the United States.
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Key Components of New Drug Applications
The NDA and MMA processes share standard components that include:
- Drug Information: This component provides an in-depth summary of the drug, its chemical structure, production methods, and specifications.
- Clinical Data: An essential part of the NDA is clinical trial data revealing results from preclinical studies and all phases of clinical trials. This information demonstrates the drug’s safety, efficacy, and therapeutic benefits.
- Quality Control and Manufacturing: This component includes information about the drug’s manufacturing processes, facilities, and adherence to GMP standards and quality control procedures.
- Labeling and Packaging: The application must include proposed labeling and packaging information, ensuring that the drug’s dosage recommendations, prescribing information, and packaging details comply with regulatory standards.
- Regulatory Compliance: Regulatory agencies require evidence of the drug’s compliance with Good Manufacturing Practices (GMP) and other regulatory standards. This component provides documentation that supports compliance with these requirements.
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:
- Submission of eligibility request 7-18 months before submission of marketing authorisation application.
- Notification of intention to submit an application seven months before submission of marketing authorisation application.
- 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.
- 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.
- 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:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- 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.
Quality Assurance | Safety and Efficacy |
GMP is a mark of quality. Compliance with GMP standards ensures products are manufactured to high standards, including consistency, equipment, employee training, testing, and facility design. | GMP-certified products undergo robust quality control and testing procedures to ensure they are consistent, safe, and effective. This is absolutely critical for substances intended for human consumption. |
Regulatory Compliance | Supply Chain Reliability |
GMP is recognized worldwide as the leading standard for producing and distributing APIs. Many regulatory authorities, including the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) require GMP compliance for product approval and marketing. | GMP covers the entire supply chain to make sure your products are top quality from start to finish, including raw material sourcing, storage, and transportation. Choosing GMP-certified APIs ensures supply chain integrity and reduced risk of poor-quality, counterfeit, or contaminated products. |
About MedicaPharma
MedicaPharma is a trusted and fully licenced API distributor based in Europe that leverages a global network of GMP manufacturers to supply high-quality API’s and pharmaceutical intermediates to healthcare organizations all over the world.
Different countries and jurisdictions may have varying regulatory requirements, with poor enforcement of relevant rules and regulations. There may be accountability and transparency issues associated with manufacturing and distribution, which increases your risk of receiving non compliant products.
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Learn More About New Drug Applications
Staying informed about abbreviated new drug applications helps you stay knowledgeable about the industry, trends in healthcare and biotechnology, and new business opportunities. EU-based MedicaPharma, a trusted pharmaceutical distribution partner, can help your research organization, educational institution, or patient care clinic stay current on new developments and emerging business ventures.
Contact us to learn more about new drug applications and their impact on your business.
New Drug Application FAQ
A New Drug Application (NDA) and an Investigational New Drug Application (IND) are both regulatory submissions to the US Food and Drug Administration (FDA), however they differ in terms of development stages. The IND is submitted before conducting clinical trials on a new drug or a new use for an existing approved drug. In contrast, the NDA is submitted following the completion of clinical trials.
New drugs undergoing the application process are typically unavailable to the general public, however patients may be accepted during clinical trials as part of the Investigational New Drug (IND) application process.
For the European Union, the steps include submitting an eligibility request, notification of intention to submit an application, appointment of rapporteurs, pre-submission meetings, and re-confirming the submission date.
The drug development process in the United States includes the following steps: 1. Discovery and Development, 2. Preclinical Research, 3. Clinical Research, 4. FDA Review, and 5. FDA Post-Market Safety Monitoring.
Contact MedicaPharma to learn more about new drug applications and how they impact your research institution, health organization, or commercial business.
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