Scribd Logo
Upload

Welcome to Scribd!

  • 45 views

    Welcome To Seminar ON Drug Regulatory Affairs: Preparad by:K.SLRAO (Mpharm.1yr)

    Uploaded by

    Kallepalli Somalingeswara Rao
    The document provides an overview of drug regulatory affairs and the role it plays in supporting the pharmaceutical industry. It discusses how regulatory affairs provides guidance to streamline the drug development process, which can take 8-15 years and cost over $800 million. It also lists several key drug regulatory authorities around the world and outlines the various stages of product development that regulatory affairs provides input and submissions for, including licensing, manufacturing, and marketing approval. The goal of regulatory affairs is to interface between departments and regulatory bodies to help avoid delays and issues in bringing a safe and effective drug to market.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd

    Welcome To Seminar ON Drug Regulatory Affairs: Preparad by:K.SLRAO (Mpharm.1yr)

    Uploaded by

    Kallepalli Somalingeswara Rao
    45 views11 pages
    The document provides an overview of drug regulatory affairs and the role it plays in supporting the pharmaceutical industry. It discusses how regulatory affairs provides guidance to streamline the drug development process, which can take 8-15 years and cost over $800 million. It also lists several key drug regulatory authorities around the world and outlines the various stages of product development that regulatory affairs provides input and submissions for, including licensing, manufacturing, and marketing approval. The goal of regulatory affairs is to interface between departments and regulatory bodies to help avoid delays and issues in bringing a safe and effective drug to market.

    Original Title

    ttyhrhrhryh

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document provides an overview of drug regulatory affairs and the role it plays in supporting the pharmaceutical industry. It discusses how regulatory affairs provides guidance to streamline the drug development process, which can take 8-15 years and cost over $800 million. It also lists several key drug regulatory authorities around the world and outlines the various stages of product development that regulatory affairs provides input and submissions for, including licensing, manufacturing, and marketing approval. The goal of regulatory affairs is to interface between departments and regulatory bodies to help avoid delays and issues in bringing a safe and effective drug to market.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    45 views11 pages

    Welcome To Seminar ON Drug Regulatory Affairs: Preparad by:K.SLRAO (Mpharm.1yr)

    Uploaded by

    Kallepalli Somalingeswara Rao
    The document provides an overview of drug regulatory affairs and the role it plays in supporting the pharmaceutical industry. It discusses how regulatory affairs provides guidance to streamline the drug development process, which can take 8-15 years and cost over $800 million. It also lists several key drug regulatory authorities around the world and outlines the various stages of product development that regulatory affairs provides input and submissions for, including licensing, manufacturing, and marketing approval. The goal of regulatory affairs is to interface between departments and regulatory bodies to help avoid delays and issues in bringing a safe and effective drug to market.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 11

    WELCOME TO SEMINAR ON DRUG REGULATORY AFFAIRS

    Preparad by:K.SLRAO(mpharm.1yr)

    DEFINATION:

    Pharmaceutical industry is the most regulated of all

    the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million. Regulatory affairs provides insight/guidance into this development through agency wisdom collected in guidance, previous experience, market precedence, etc. and hence helps to reduce number of development failures

    Drug Regulatory Authorities (across the world) CDSCO- India


    USFDA- United States EMEA-(Europe, the Middle East and Africa)European countries MHRA- (Medicines and Healthcare products Regulatory Agency)United Kingdom

    TGA- Australia
    MCC- (Medicines Control Council) South Africa Product Development Clinical Research & Trials Licensing

    Manufacturing
    Quality Assurance & control Marketing

    Licensing Registration

    Development
    Manufacturing Quality Guidance Pricing Marketing

    Pharmacovigilance
    GMP ,GLP ,GCP, Patent, Copyright ,Trademark

    Investigational New Drug Application (IND)


    New Drug Application (NDA) Abbreviated New Drug Application (ANDA)

    Biological License Application (BLA)


    For Market Authorization For GMP certification For getting Certificate of Pharmaceutical Products

    For obtaining Patent, Copyright and Trademark registration.

    Licenses and certificates obtained by Drug

    regulatory Authorities, Eg. Mfg. License, GMP, CoPP, ISO etc. Common Technical Document (CTD/eCTD) ASEAN Common Technical Document (ACTD) Drug Master File Clinical Trial Reports Bioavailability & Bioequivalence reports Quality Audit files and reports &

    Provide regulatory and technical inputs for product development.


    Prepare, review and submit different

    regulatory submissions. Act as interface between internal department of organization

    review and submit annual drug reviews, adverse drug experience, recall coordination activities and different regulatory guidelines answer and negotiate with the drug regulatory authorities on various issues on drug registration. apply for the various certifications and arrange for the audit and also work on their renewal. .& many more.

    The above discussion proves that the DRA department is providing its full support to all the department of a pharmaceutical organization and also to the Drug Regulatory authorities on all aspects of Drug development process.
    This in turn helps to avoid any delay or

    problems that can arise in future relating to the Product, hence save a lot of time, efforts and expenditure

    THANK YOU

    You might also like