4th sem copy
- 1. Regulations of Biologics in India, USA & EU – A Comparative Study Presented by :- Mr. Doninder (1852) M Pharma (SEM-IV) Guided By….. Dr. Vikas Budhwaar Assistant Professor(Pharmaceutics) Department of Pharmaceutical Sciences Maharshi Dayanand University Rohtak
- 2. Introduction “Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies and used to treat a variety of medical conditions for which no other treatments are available”- USFDA These products are Sera, Vaccine, Blood & Blood Products, Insulin, Toxin-Antitoxin, Pituitary extract, Antigens, Monoclonal Antibodies, recombinant therapeutic protein etc. 1st vaccine – Small Pox (1798)Edward Jenner
- 3. . STAGE Agency Involved Application Manufacturing license for test, analysis and examination State FDA/CDSCO FORM 30 Preclinical studies permission RCGM FORM C3 Submission of preclinical study report RCGM FORM C5 Clinical trial CDSCO FORM 44 Manufacturing and marketing permission CDSCO FORM 44 Form 46A(Bulk Product) Manufacturing license State FDA/CDSCO FORM 27D Registration and import license CDSCO FORM 40/FORM 8
- 5. Regulations in USA - FDA is supreme regulatory body consist of different types of departments or offices. CDER – Drugs CBER – Biologics Biosimilars are approved or review – 351(k) pathway Biologics approved by PHSA Insulin, growth hormone, peptide approved by FDCA Alpha amino acid > 40 = Protein Alpha amino acid < 40 = Peptide Alpha amino acid < 1000 = chemically synthesized polypeptide
- 7. Applications & form IND – information of preclinical study - need for conduct human clinical trial - effect into 30 days after the FDA received BLA – for commerce of biologics permission (21CFR 601.2) - Submission 2 copies of BLA 1. Archival Copy – blue cover 2. Review Copy – divided into 6 sections Post approval requirements – require annual report, manufacturing & labeling changes, periodic cGMP inspections. NDA – for marketing of new drug - used by CDER
- 8. . FDA 356h – application to market a new drug or abbreviated new drug or biologics FDA 3356 – registration and list of establishment for human, tissue and cellular cells and tissue based product. FDA 3486 – biological product deviation report VAERS form – Vaccine Adverse Event Reporting System
- 9. Regulations in EU - EU has pioneered the regulation of biosimilars. - approved 1st biosimilar medicine - approved through EMA - human medicinal product related committee CHMP(The Committee for Medicinal Products for Human Use) - section 4, part II Anes I, Directive 2001/83/EC - Guideline on similar biologics containing biotechnology-derived protein (EMA/CHMP/BWP/247713/2012) quality issue - (EMEA/CHMP/BMWP/42832/2005 Rev) non clinical and clinical issues - 2001: Dir. 2001/83 = CHMP - 2003: Dir. 2003/63 = Biosimilars
- 11. Need for regulations Sr. Tragedies Name Year Place 1. BCG Vaccine 1930 German city 2. Oral Polio Vaccine 2005 UP 3. Anti-Measles & Tetanus Vaccine 2010 Bhopal 4. HPV Vaccine 2010 AP 5. Pentavalent Vaccination 2011 Hr, Maharastra, AP 6. Polio Vaccine 2011 All over India 7. Hepatitis B 2013 Calcutta 8. Infected Blood Transfusion 2016 All over
- 12. Work to be done To understand the regulation for newly developed biologics and biosimilars in EU. Study the global vaccination programmes. Details analysis of worldwide case studies of biologics
- 13. REFERENCES Proposed guidelines for similar biologics, CDSCO Key Regulatory Guidelines for the Development of Biologics in the United States and Europe RICHARD KINGHAM, GABRIELA KLASA, and KRISTA HESSLER CARVER2 FDA Regulatory Affairs – Aguide for prescription drugs, medical device, and biologicsDouglas J. Pisano, David S. Mantus https://www.transparencymarketresearch.com/glo bal-biologics-market.html https://www.pmda.go.jp/files/000152421.pdf http://www.imapac.com/wp- content/uploads/2015/03/BiosimilarWorldIndia201 5_S-R-Rao-Government-of-India.pdf