COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 1
Abstract
A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.
Authors and Affiliations
Konuri Dinesh Chandra, Mamillapalli S, A. Elphine P, Desu Brahma S. R.
Keywords
Related Articles
- EP ID EP338400
- DOI -
- Views 99
- Downloads 0
Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)
Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical c...
FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES
India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector. Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry curre...
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM
A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that t...
REGULATIONS OF ORPHAN DRUGS IN USA, EU AND INDIA-A COMPARATIVE STUDY
Orphan drugs are the drugs and natural products used in treatment, diagnosis, or prevention of rare disease. The orphan drug regulation varies in different countries. Initially a guideline (Orphan Drug Act) for orphan dr...
EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS
Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming pr...