Although all countries have a different regulatory procedure for new drug approval and market a particular drug worldwide, the drug has to pass through the Marketing Authorization Application (MAA) of different countries.
As USA plays an essential role worldwide in distribution and marketing drugs, one should know NDA Regulatory Services and its rules in USA.
NDA is a process regulated by the FDA to import or manufacture a new drug by an individual/organization/company and provide authorization to market and sell the product.
Let’s study the new drug approval procedure briefly.
To apply for new drug approval, one has to fill Form 44 under schedule Y of the Drug and Cosmetics Act 1940 & rules 1945. The schedule Y is revised in 2005 to bring the NDA regulatory process to the international level.
For new drug approval to FDA, the details of the drug, e.g., drug information, manufacturing process, description, and labeling, must be properly made according to rules by DCGI. Under CDSCO, DCGI looks after the clinical research.
A drug approval process is a long-term process which c consists of mainly 4 stages, which are as follows:
- Application to conduct clinical trials
- Conducting clinical trials
- Marketing and sell of the approved drug
- Post-marketing effects
Phases of Clinical trial for new drug application:
• Preclinical stage- the test has to be made on mice, rats, rabbits, and monkeys to ensure the drug’s safety and potential success.
Then it goes through clinical trials:
- Phase- I- Human pharmacology- to test the drug’s tolerance, specific effects, and how safe the new drug is.
- Phase- II- Exploratory trial- To see the effectiveness and side effects of the new drug.
- Phase -III- Confirmation trial- To examine any therapeutic effects of the applied new drug.
- Phase-IV- Post-marketing trial- In which DCGI look over the after results and effects of the drug supplied to the market
Rules in USA for Drugs and Cosmetics
- The regulations under the Drugs and Cosmetics Act 1940 and its rules 1945 of 122A states that if a drug is already approved and used in other countries for long years, then the clinical trial of that drug may be waived.
- Section 2.4 (a) under the Drugs and Cosmetics Act 1940 and its rules of 1945 states that a new drug discovered must be got through all stages of clinical trials and approval.
- Section 2.4 (a) of the Drugs and Cosmetics Act 1940 and its rules 1945 states, a drug which is not discovered in USA but it is used in other countries, DCGI may order to repeat all the procedures from the beginning, including all clinical trials or may allow him to start from Phase-III clinical trial.
- 122A, B, D of Drugs and Cosmetics Act 1940 and its rules 1945 describe all the required information required for the drug approval.
- 122 DAB of Drugs and Cosmetics Act 1940 and its rules 1945, strictly adhere to compensation to side effects patients’ death during clinical trials.
Conclusion: The above rules come under practice in USA. Basically, for the new drug approval process, two steps play a vital role: the clinical stage and the approval and authorization to marketing and sell.