GMP- A Regulatory Perspective

Regulatory Perspective in entering Global Pharma Markets

Regulatory Perspective in entering Global Pharma Markets World wide market of pharma products: 1 Trillion $. Growth is 5-7 % Out of this about 40% is in North America.

Regulatory Perspective in entering Global Pharma Markets Global Pharma Market : mainly divided in 2 (basis of Economy & regulatory controls) Regulated market(countries) (US,EU,Japan & Australia,Newzeland) Emergent markets (countries). (Rest of world)

Regulatory Perspective in entering Global Pharma Markets Countries with out established systems for controls: WHO Regulations: For Health matters & WTO regulations : For Trade Regulations

Regulatory Perspective in entering Global Pharma Markets For New organization: Type of products to be exported: a. General case b. Products using impermeable containers c. Products using semi-permeable containers d. Products require refrigeration e. Stored in freezer.

Regulatory Perspective in entering Global Pharma Markets Select Area for use of products.(intended export) Zone I : Temperate Zone II : Subtropical(possible high humidity) Zone III: Hot/Dry Zone IV: Hot/Humid

Regulatory Perspective in entering Global Pharma Markets Statement of labeling : Based on stability studies it should be very specific for storage conditions. ( terms like ambient temperature/ room temperature not to be used) Other details according to local legislations in addition to mfg & expiry details.

Regulatory Perspective in entering Global Pharma Markets For US : largest market and most regulated. 3 categories: NDA Abbreviated NDA Mix of both i.e. 505(b) 2 Birth of Generic industry in US 1984: Drug price competition & patent term restoration act.

Regulatory Perspective in entering Global Pharma Markets Different types of ANDAs Para. I : Products with no patent information Para II: Products whose patents expired. Para III: Patents are available but products will be marketed after expiry of products. Para IV: Patents are valid, but new product does not infringe those patents or applicant invalidates the granted patents

Regulatory Perspective in entering Global Pharma Markets CANADA NDS New Drug Submission ANDS for generic products Submission to Health Products & Food Branch (typical scientific information about safety, efficacy and quality of products)

Regulatory Perspective in entering Global Pharma Markets CANADA (contd) Supplemental NDS (SNDS) when there is change in formulation, method or strength or route of administration, labeling or expand the indication.

Regulatory Perspective in entering Global Pharma Markets EUROPE (European Economic Area) 27 countries EMA controls the authorization in EEA Centralized procedure for products of biotechnological process, new molecules for cancer, aids, diabetes, viral diseases, orphan drugs, auto immune diseases, new radiopharmaceutical active substance.

Regulatory Perspective in entering Global Pharma Markets EUROPE (contd) Decentralized procedure for drugs which are out of scope of centralized procure. Mutual recognition procedure is adopted if applicant wants to extend his market after receiving marketing authorization in one member state. National marketing authorization is used my member states for products out of mandatory centralized procedures.

Regulatory Perspective in entering Global Pharma Markets JAPAN Second largest market next to US 11% of global sales. Pharmaceutical and Medical Devices Agency under Ministry of Health, labour & welfare handles approvals, licensing and post marketing safety.

Regulatory Perspective in entering Global Pharma Markets JAPAN (contd) J-NDA & J-ANDA are submitted to PMDA. PMDA review technical data, consults various councils and refers to MHLW for evaluation for medical needs, social issues in addition to scientific review for final approvals.

Regulatory Perspective in entering Global Pharma Markets Emerging nations: Rest of the World Asia Pacific, Latin America, Eastern Europe, Africa & Gulf countries. This market is more than 10%. Environment is regulated through ASEAN( Association of Southeast Asian Nations) and GCC(Gulf Cooperation Council).

Regulatory Perspective in entering Global Pharma Markets Emerging nations: Rest of the World(contd) Application is made through ASEAN Common Technical Dossier(ACTD) and same document can be used for non member nations with minor modifications.

Regulatory Perspective in entering Global Pharma Markets Other factors: Patent Scenario & Exclusivities: Data exclusivity and other exclusivities are available to promote the company engaged in incremental innovations.

Regulatory Perspective in entering Global Pharma Markets Components of Regulatory Filing: As per ICH guidelines through common Technical Documents (CTD)in five modules(1- 5) Module 1: Regional & administrative details Module 2: Overall summary Module 3: Quality Module 4: Safety Module 5: Efficacy

Regulatory Perspective in entering Global Pharma Markets Indian regulations: India: leading supplier of generic drugs & API Regulatory requirements as per Drugs & Cosmetics Act Licenses: Test License: Form 29 Import License: Form 10 & form 11 NOC for BE Manufacturing License: Form 25/ Form 28

Regulatory Perspective in entering Global Pharma Markets Thanks for patient hearing.