The document discusses current and future regulation of biological products by the Korea Food and Drug Administration (KFDA). It provides an overview of the KFDA's functions in regulating biological product quality, registration processes, relevant laws and guidelines. It also discusses specific areas like viral product control and challenges in regulating this emerging field.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Journal Club: Telomere Length And Cortisol Reactivity In Children Of Depresse...Ashutosh Ratnam
Here's a Journal Club Presentation I made on the article 'Genetic Predisposition to Schizophrenia Associated with Increased Use of Cannabis' which appeared in the Sep 14 issue of Molecular Psychiatry. It examined and found a correlation between shortened telomere length in women and a risk for depression in their daughters.
VLE Data - Selection and Use
0 INTRODUCTION/PURPOSE
1 SCOPE
2 FIELD OF APPLICATION
3 DEFINITIONS
4 DIAGRAMMATIC REPRESENTATION OF IDEAL
AND NON-IDEAL SYSTEMS
4.1 Ideal Mixtures
4.2 Non-Ideal Mixtures
5 REVIEW OF VLE MODELS
5.1 Ideal Behavior in Both Phases
5.2 Liquid Phase Non-Idealities
5.3 High Pressure Systems
5.4 Special Models
6 SETTING UP A VLE MODEL
6.1 Define Problem
6.2 Select Data
6.3 Select Correlation(s)
6.4 Produce Model
7 AVOIDING PITFALLS
7.1 Experimental Data is Better than Estimates
7.2 Check Validity of Fitted Model
7.3 Check Limitations of Estimation Methods
7.4 Know Your System
7.5 Appreciate Errors and Effects
7.6 If in Doubt – Ask
8 A CASE STUDY
8.1 The Problem
8.2 The System
8.3 Data Available
8.4 Selected Correlation
8.5 Simulation
8.6 Selection of Model
9 RECOMMENDED READING
10 VLE EXPERTS IN GBHE
APPENDICES
A USE OF EXTENDED ANTOINE EQUATION
B USE OF WILSON EQUATION
C USEFUL METHODS OF ESTIMATING
D EQUATIONS OF STATE FOR VLE CALCULATIONS
TABLES
1 SUMMARY OF VLE METHODS
2 LIST OF USEFUL REFERENCES
FIGURES
1 VAPOR-LIQUID EQUILIBRIUM - IDEAL SOLUTION
BEHAVIOR
2 VAPOR-LIQUID EQUILIBRIUM - A GENERALISED
Y-X DIAGRAM
3 VAPOR-LIQUID EQUILIBRIUM - MINIMUM BOILING
AZEOTROPE
4 VAPOR-LIQUID EQUILIBRIUM - MAXIMUM BOILING
AZEOTROPE
5 VAPOR-LIQUID EQUILIBRIUM - MINIMUM BOILING
AZEOTROPE -TWO LIQUID PHASES
6 SENSITIVITY TO ERROR IN VLE DATA (BASED ON FENSKE EQUATION)
7(a) FITTING WILSON 'A' VALUES TO VLE DATA - CASE A
7(b) FITTING WILSON 'A' VALUES TO VLE DATA - CASE B
7(c) FITTING WILSON 'A' VALUES TO VLE DATA - CASE C
As the smallest physical unit of light, biophotons are stored in and used by, all biological organisms. Research on the purpose of these biophotons is proving important in modern science, and they may very well be in controll of every biochemical reaction that occurs in our body, including supporting the body's ability to function. It is an aspect that is an important aspect in the design and creation of Biodisc 2.
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: James Ault, VP Regulatory Affairs, Ricerca BioSciences
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxsodhi3
Regulatory Compliance in Pharmaceutical Development:
GLP & GMP
Jeffrey G. Sarver, Ph.D.
MBC 3100
March 8, 2016
email questions to:
[email protected]
*
Food and Drug Administration (FDA)Agency of U.S. Department of Health and Human Services (HHS)Protect public health and provide essential public servicesOther HHS agencies include: CDC, NIH, Medicare/MedicaidFDA responsible for assuring safety and efficacy of: Human Drugs - Center for Drug Evaluation and Research (CDER)Veterinary Drugs - Center for Veterinary Medicine (CVM)Biological Agents - Center for Biologic Evaluation and Research (CBER)Medical Devices - Center for Devices and Radiological Health (CDRH)Food/Supplements/Cosmetics - Center for Food Safety and Applied Nutrition (CFSAN)
Manufacture
Market Drug
NDA
FDA Review
Clinical
Trials
I, II, III
IND
FDA Review
Preclinical
Testing
Drug
Discovery
Drug Development/Approval ProcessIND – Investigational New Drug application (3-6 yr, $5M-$10M)FDA Approval → Proceed into Clinical Trials (~30% from preclinical tests)Clinical Hold → Collect More data or End DevelopmentNDA – New Drug Application (9-12 yr, $500M-$1B)FDA Approval → Drug Enters Market (~8% from preclinical tests)Not Approved → More Data or Adjust Application or End Development
Basic
Research
+
Target
Discovery
Preclinical Testing RequirementsMechanism of Action (in vitro) and Efficacy (in vivo)General Toxicology: Single and Repeated Dose (in vivo)Genotoxicity/Mutagenicity (in vitro/in vivo)Carcinogenicity (in vivo)Reproductive Toxicology/Teratology (in vivo)ADME (in vitro)/Pharmacokinetics (in vivo)Additional Safety TestingCore: Cardiovascular (hERG), Respiratory, CNSOther tests as needed based on structure, mechanism, general tox
Additional Information for INDChemistry, Manufacturing, and Controls (CMC)Structure, physical propertiesSynthetic method and scale-upPurity, identification of impuritiesDosage form/route, formulation, preparation, packagingClinical Study ProtocolsPrevious Human Experience (if available)
FDA Guidance Documents
Information on suggested: testing methods, analyzing and summarizing data
Can be found at: http://www.fda.gov/RegulatoryInformation/Guidances/Searching can be difficult/tedious, use appropriate filters:Product → Drugs (or Biologics)FDA Organization → CDER (or CBER)Document Type → Guidance DocumentsExample Guidance Documents available on Blackboard:Genotoxicity TestingCardiotoxicity (hERG) TestingChemistry, Manufacturing, and Controls (CMC) for Phase I DrugMaximum Safe Starting Dose for Clinical Testing
International Council on Harmonization (ICH)Harmonize procedures for evaluating/reporting safety, efficacy, CMC in multiple regions/countriesRegulators and industry representatives from participating regions collaborate to generate internationally acceptable guidelinesImprove efficiency of drug testing/reporting requirements for approval in multiple countriesOriginally Europe, Japan, U.S.Other countries adopting IC ...
The presentation on ICHGCP guidelines overview.The presentation gives a detailed view of What is ICHGCP, Principles of ICH & GCP
IRB & IEC, Investigator, Sponsor, Clinical trial Protocol
Investigator brochures & Essential documents.
Similar to Quality regulation for biological products current and future (20)
Quality regulation for biological products current and future
1. Quality Regulation for Biological Products: Current and Future Sue Nie Park, Ph.D. Director, Division of Viral Products Center for Biologicals Evaluation Korea Food & Drug Administration
11. Quality Regulation System Network Manufacturer NCL NRA RA * QA QC Production Final lot New drug approvals Changes to drugs Compliance with regulations Consequences of violations Do as a “gatekeeper” Inspection: regularly once every 2 years RA *: Regulatory Affair
12. The Process of Biological Products Licensure in Korea Pre-clinical & clinical reports Specifications & Test methods KFDA Simultaneously or separately application Licensure Market Submit a post-marketing surveillance report to KFDA by 5 years after approval Pre-approval Post-approval According to “Provision for Inspection of Request on Specifications and Test Methods of Drugs (No. 2001-9, Feb 16 2001 revised)
14. Approval Process in Europe: Overview Determine Product Status Select a Rapporteur country (if France, AFSSAPS)) Apply to other EU members** Non Therapeutic Effect Submit to AAFSSAPS Therapeutic Effect Centralized Procedure Mutual Recognition Procedure * Based on rapporteur country’s authorization In France: additional submission to Transparency Commission Apply to EMEA
15. Overall relationship between NRA and Drug Manufacturer Unapproved Products IND initial CMC Amendments Annual Reports Lot Release Process Changes BLA (CMC) Inspections Inspections Regulatory Authority REVIEW REVIEW Compliance Action Approved Products Changes to Procedures Annual Reports Adverse Reactions License Updates Regulatory Affairs Legal Quality Control Marketing Customers Licensors Manufacturing Clinical Supplier Product Development Licenses Management Quality Assurance
34. Licence for Pharmaceutical manufacturer Receipt Order & Review for Facility inspection Completion for Facility inspection & Review Proposal & Approval Issue of certificate for Pharmaceutical manufacture Report Facility inspection Order Fill-up of application form Release Transaction adminstration KFDA Via department (Regional KFDA) Applicant
35. Applicant Registration Process of NDA Safety & Efficacy application Specification and test methods application Safety Evaluation Office NITR Central Pharmaceutical Affair Council Evaluation Council In KFDA (If necessary) Review Result Notification Review Result Notification Applicant NDA Biologics Department NDA Action
36. IND Application Process PreIND Meeting Application IND Plan PreIND Meeting Notification of Application Eligiblity IND (or its amendment) Application 1 2 Was there a PreIND? Review Initiation at PreIND Meeting level Protocol No IND (or its amendment) Approval Yes Trial Ongoing Reporting of CT completion NDA Application Final PL Approval If necessary, forwarding to KCPAC IND Requisite Dossier
37. IV. Law and Ordinances Related to Biologicals Approval
38. System of and ordinances Pharmaceutical Affairs Law (PAL) Pharmaceutical Enforcement Ordinance(PEO) Pharmaceutical Enforcement Regulation(PER) Notice, Guidance’…etc
39. Laws and Regulations concerned with Biologicals Approval Article 85~88 Article 64 KFDA Notice 1999-39 Article 11.40 Article 19,31 Article 26-3 KFDA Notice 1999-11 Article 30,31 Article 26-2 Re-examination of New drug Re-evaluation of drug PMS Adverse reaction monitoring GMP Inspection Article 62~70 Article 45 Lot release KFDA Notice 2000-49, 1997-67, 1999-6, 2001-9, 2001-35 Article 23, 24, 27, 27-2 ,28,29,83 Article 26 Product Licence KFDA Notice 2000-49 Article 22 Article 26 Licence for Pharmaceutical manufacture Notice…etc PER PEO PAL
46. V. Control of Viral Products August 2003 Division of Viral Products Center for Biologics Evaluation Korea Food and Drug Administration
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49. Organization & Responsibilities QM Crosscheck QM Approval Hep B (plasma) HIV/HepB agn/aby test Hep A JE HFRS Influenza OPV IPV Interferon Clonorchis sinensis agn Paragonimus westermani agn MMR VZV
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55. Test Items for Lot Release : Inactivated Vaccines or Antigens, 2003
56. Test Items for Lot Release : Live Attenuated Vaccines, 2003
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59. Potency Standards / Reference Reagents for Viral Vaccines Manufacturer’s in house reference IPV Asan Institute for life science (WHO collaborating center for viral reference) HFRS 2001 (Established) Korea National Biological Standard JE (inactivated) NIBSC Influenza HA & Split " Hepatitis A vaccine Manufacturer’s in house reference Hepatitis B vaccine (plasma) Comment Sources Manufacturer’s in house reference Korea National Biological Standard " " OPV 2002 (Established) Varicella vaccine Mumps vaccine Measles vaccine Vaccines
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61. Summary on Annual Activities (’96-’01) *1 Including 25 withdrawals *2 Including 2 withdrawals and 1 rejection