New Drug Approval Process .pptx

This New Drug Approval Process

The new drug approval process is a complex and rigorous process that pharmaceutical companies must go through in order to bring a new drug to market. The process is designed to ensure that new drugs are safe and effective for their intended use.

The new drug approval process typically takes several years to complete and involves the steps mentioned in presentation

1. Shri Vile Parle Kelavani Mandal's Institute of Pharmacy, Dhule Approved by PCI, AICTE, DTE Affiliated to Dr. Babasaheb Ambedkar Technological University Mr. Saurabhasing J Rajput PRN NO : 2254482817012 (MPH103T) Pharmaceutical Regulatory Affairs NDA Approval Process M Pharm 1 st year Sem. I Department of Pharmaceutics

2. 2 Drug Discovery Process NDA Introduction USFDA NDA Classification NDA Format Flowchart Points To Be Discussed

3. 7 DRUG New Drug Drug Product

4. 8 Drug Discovery Process

5. 9 NDA classifications Introduction : If clinical studies confirm that a new drug is relatively safe and effective, and will not pose unreasonable risks to patients, the manufacturer files a New Drug Application (NDA), the actual request to manufacture and sell the drug in the United States. NDA New Molecular Entity NDA New Salt of Previously Approved Drug NDA New Formulation of Previously Approved Drug NDA New Combination of Two or More Drugs with New Indication NDA Already Marketed Drug Product - No Previously Approved FDA

6. 10 Drug approval in United States History 10 1906 Food & Drug Act Congress passed the original Food and Drugs Act, which require that drugs must meet official standards of strength and purity. Kefauver Harris Amm. Act The Kefauver-Harris Amendment Act was passed which require that manufacturers must prove that drug is safe and effective (for the claims made in labelling). . 1962 Pharmacopeia The new era of USA drug regulation was started with the establishment of U.S. Pharmacopoeia . . 1820 Sulphanilamide Tragedy Due to Sulphanilamide tragedy, the Federal Food, Drug and Cosmetic Act (of 1938) was enacted and added new provisions that New drugs must be shown safe before marketing. . 1937

7. 11 FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. Why USFDA ? oldest consumer protection agency world’s most stringent standards Most demanding in the world. FDA Approval Means : Data on the drug’s effects have been reviewed by CDER Mission Inspections and Legal Sanctions Scientific Expertise Product Safety FDA Divisions CDER CBER CDRH CVM

8. 12 CDER’s Mission Promote the Public Health by ensuring the availability of safe & Effective drugs Protect public health by promoting the safe use of marketed drugs. Protect public health by ensuring quality & integrity of marketed drug products Office of Pharmaceutical Science Office of Generic Drugs Office of New Drug Chemistry Office of Pharmacology & Biopharmaceutics Office of Testing & Research Center for drug evaluation & Research [ CDER ]

9. 13 All New Drug Applications must contain the information required in 21 CFR 314.50 Two copies of the application are needed: an archival copy and a review copy. General Overview OF NDA Review Copy Divided in to five or six section containing technical and scientific information separately bound Each section of the review copy should also contain a copy of Volume 1.1 with the following: A copy of the FDA cover letter A copy of the application form (FDA 356h) A copy of the index to the entire application A copy of the overall summary A copy of a letter of reference or authorization to access NDAs, DMFs, etc.

10. 14 Folder Colors & Form Numbers Document Folder color Form number Archival copy Light blue FD 2626 Chemistry, manufacturing, and controls section (CMC) Red FD 2626a Nonclinical pharmacology and toxicology section Yellow FD 2626b Human pharmacokinetics and bioavailability section Orange FD 2626c Microbiology section White FD 2626d Clinical data section Light brown FD 2626e Statistical section Green FD 2626f Field copy Maroon FD 2626h

11. 15 FOLDER Color of Folder Ex. Blue For Archival copy Paper Size & Binding Page 8.5 – 11 inches Bound at left side Accurately no Pagination Page no of both copy should have same Volume size Not more than 2 inches thick Should have name of applicant, drug and - NDA no Packing carton Box size 14 -12- 9.5 inches Assembling of the Application

12. 16 NDA Application summary requirement Annotated Package Insert Pharmacological Class, Scientific Rationale, Intended Use, and Potential Clinical Benefits Foreign Marketing History CMC Drug Substance Drug Product Nonclinical Pharmacology and Toxicology Summary Human Pharmacokinetics and Bioavailability Summary Microbiology Summary Clinical Data Summary and Results of Statistical Analysis Discussion of Risk / Benefit Relationship .

13. Chemistry, Manufacturing, and Control Nonclinical Pharmacology and Toxicology Pharmacology Trials Acute Toxicity Trials Sub chronic/Chronic/Carcinogenicity Trials Special Toxicity Trials Reproduction Trials Mutagenicity Trials Human Pharmacokinetics and Bioavailability Section Microbiology Clinical Data Section Outline of the Clinical Section Other NDA Requirements The Integrated Clinical/Statistical Report Samples, Methods Validation, and Labeling Case Report Forms and Tabulations 17 NDA Technical Section

14. A. Application Form List of INDs, NDAs, and DMFs referenced in the Application B. Patent Certification C. Application Summary D. Technical Data Sections : (1) Chemistry, Manufacturing and Controls Section (2) Nonclinical Pharmacology and Toxicology Section (3) Human Pharmacokinetics and Bioavailability Section (4) Microbiology Section (5) Clinical Data Section 18 NDA Format [FDA 356 # 3, 21 CFR 314 . 50(C)

15. 5. Clinical Data Section : a. List of Investigators b. Background/Overview of Clinical Investigations c. Clinical Pharmacology Trials d. Controlled Clinical Trials e. Uncontrolled Clinical Trials f. Other Trials and Information g. Integrated Summary of Efficacy h. Integrated Summary of Safety i . Drug Abuse and Overdosage Information j. Integrated Summary of Benefits and Risks k. GCP Statement l. Transfer of Obligations m. List of Audited Trials 19

16. 6. Statistical Data Section : a. Controlled Clinical Trials ( i ) Table of Controlled Clinical Trials (ii) Table of Contents—Reports of Controlled Clinical Trials . b. Integrated Summary of Efficacy c. Integrated Summary of Safety d. Risk Benefit Assessment E. Samples and Labeling F. Case Report Forms and Tabulations a. Case Report Form Tabulations Table of Contents b. Case Report Forms for Subjects Who Died or Discontinued 20

17. 21 NDA Review Flowchart

18. 22 NDA review Procedure Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug. Chemistry Clinical Statistics Biopharmaceutical Microbiology FDA Advisory Committee Arises Questions Expert advice Patient Representative organize a meeting

19. 23 Drug approval process in India

20. Common Technical Document

21. WWW.fda.gov WWW.ich.org/page /multidisciplinary-guidelines www.cdsco.gov.in The New Drug Application, Content and Format Richard A.Guarino Oxford Pharmaceutical Resources, Inc., Totowa, New Jersey, U.S.A. 25 References

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