How do I register a new drug?

How do I register a new drug?

Applications for Registration/ Import License of New Drugs shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 /23236975. Fax: 91-11-23236973, as per Drugs & Cosmetics Rules in India.

How do I get FDA approval in Thailand?

Importing controlled food products into Thailand requires registration with the Thai FDA and labels must be fully translated into the Thai language. The food must be analyzed, including the details of processing and the ingredients to meet Thai FDA standards; a separate manufacturing license must also be approved.

Does Thailand have a FDA?

As set forth in the DrugAct, THA-33, and THA-49, the Thai FDA is a regulatory body under the Ministry of Public Health (MOPH)’s Cluster of Public Health Service Support, and is granted control by the MOPH to protect consumer health.

How long does it take for a new drug to be approved?

There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage.

What documents are required for new drug approval?

*By Centralized Procedure; MAA-Marketing Authorization Application, IND-Investigational New Drug, CTA-Clinical Trial Authorization, DNA-Data Not Available….New Drugs – developed in India as an IND and not marketed anywhere in world.

  • Form 44.
  • Treasury Challan of INR 50,000.
  • Source of bulk drugs /raw materials.

What is drug registration certificate?

“Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.

How do I get an FDA certificate?

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

How do I get an FDA license?

The FDA Licensing Process

  1. Review the technology with the scientist and the Technology Transfer Specialist.
  2. Review the various types of licenses available for use online.
  3. Submit a License Application to the Agency-level FDA Technology Transfer Program. E-mail to: [email protected].

How do I register my medical device in Thailand?

Medical devices will be required to undergo one of three registration routes to acquire an Import License depending on their classification. Class 1 products will require a Listing, Class 2 and 3 will require a Notification and Class 4 (highest risk) will require a License.

How do I find FDA approved drugs?

To find out if a drug is approved by FDA, consumers can use two different Internet sites:

  1. Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939.
  2. The FDA “Orange Book” contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

How much does it cost to develop a new drug?

Importance The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion. Objective To estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data.

What are new drugs tested for?

The drugs are tested using computer models and skin cells grown using human stem cells in the laboratory. This allows the efficacy and possible side effects to be tested. Many substances fail this first test of a preclinical drug trial because they damage cells or do not seem to work.