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M. Pharm Final Presentation
Transcript of M. Pharm Final Presentation
Summary & Conclusion
Acknowledgements Introduction Pharmaceutical revenues in emerging markets grow significantly faster than those in Established Markets. The pharmaceutical market in Asia & Africa has quickly become the focus of global pharmaceutical companies as they seek to drive growth worldwide.
With traditionally strong markets like the US and Europe stagnating, emerging markets are gaining importance.
The present study focuses on the Asian and African countries with respect to their Generic Drug Requirements.
1. The registration requirements for Generics in “RoW Market”
2. The relative requirements country-wise and region-wise to identify the common regulatory requirements for the drug product registration and facilitate easy filing of the dossier.
The countries are: Contents Objectives Comparison of key Requirements for the registration of
ASIAN, EAST AFRICAN & WEST AFRICAN Countries for the Drug Product Development The growth outlook for generics remains robust.
An aging population,
rising healthcare spending and
increasing acceptance, coupled with favourable government policies are key growth players for generics.
More brand name drugs come off patent.
Pharma companies are increasingly turning towards emerging markets as these markets offer higher growth potential. Guide: Mr. Balamuralidhara V.
Dept. of Pharamceutics
JSSCP, Mysore Co- Guide: Mr. N. Ravi Kumar
Mankind Pharma Ltd., New Delhi Presented by: Shilpi Khattri
IInd M. Pharm
JSSCP, Mysore AFRICAN COUNTRIES ASIAN COUNTRIES ASIAN Countries Asia Map Model System for Computer-assisted Drug Registration (SIAMED) EAST AFRICAN Countries Cambodia Vietnam Myanmnar Philippines Sri Lanka Tanzania Kenya Uganda Zambia Mauritius Nigeria Ghana WEST AFRICAN Countries ASIAN COMPARISON AFRICAN COUNTRIES COMPARISON Stability Study Comparison Summary & Conclusion Keeping in mind, the value of time and money and the requirements of the industry a comparison have been made in between the Asian countries and African countries.
The comparison studies done will facilitate the easy filing of a product dossier in all the African & Asian markets in one go. This thesis gives a simplified overview of the Drug Regulatory Authority of 12 countries taken in the project and in detail regulatory requirements for filing a dossier for a generic drug product in the markets selected. List of Publications Pharmacovigilance regulations in India: A Step forward.
Clinical Research and Regulatory Affairs, June 2012, Vol. 29, No. 2 : Pages 41-45 AFRICAN Countries 1. AMELIORATING COUNTRY’S PHARMACOVIGILANCE REGULATIONS At 2nd INDO – AMERICAN PHARMACEUTICAL REGULATORY SYMPOSIUM, Ahmedabad, 2011
2. BIOLOGICS REGULATIONS IN INDIA: A PERSPECTIVE At 63rd Indian Pharmaceutical Congress, Bangalore-2011
3. CRAMS IN INDIA: WHERE DO WE STAND??? At National Seminar on eCTD Submission, Challenges & Future Perspectives, JSS College of Pharmacy, February-2012
4. NANOTECHNOLOGY : CHALLENGES IN HARMONIZING REGULATIONS At 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs, Omics, Hyderabad. November 2012 What I did at Mankind Pharma.... 1. Compiled dossiers for Tanzania, Myanmar, Sri Lanka, Zambia & Mauritius.
2. Learned to solve queries regarding dossiers.
3. Review of Documents for dossier compilation.
4. Improved on my IT skills and writing skills (regarding writing mails). Future Prespectives Continuing with studies further...
Joined Ph.D in Regulatory Affairs in my college i.e. JSS College of Pharmacy, Mysore.
My guide for Ph.D is Dr. T. M. Pramod Kumar
and Co-guide is Mr. Balamuralidhara V.
Under JSS University Acknowledgements I would like to thank... My Guide Mr. Balamuralidhara V.
Our HOD Dr. T. M. Pramod Kumar
My Co-guide Mr. N. Ravi Kumar
My Teachers Mr. M. P. Venkatesh & Mr. Valluru Ravi
Our Principal Dr. H. G. Shivakumar
Our Vice Principal Dr. P. K. Kulkarni
My Parents, My family and MY FRIENDS... Regulations, Organization Structure, Requirements and Marketing Authorization for Medical Devices Registration in South Korea Guide: Mr. Balamuralidhara V.
Dept. of Pharamceutics
JSSCP, Mysore Major Minor Objectives To discuss about:
1. Medical Device Act in South Korea.
2. Classification of Medical devices in South Korea.
3. The registration requirements for Medical Devices in “South Korea”. Regulatory Authority: Korean Food and Drug Authority Organizational Structure OFFICES FOR MEDICAL DEVICES Medical Device Act The purpose of Medical Device Act is to promote the efficient administration of medical devices and to contribute to improving the public health by stipulating regulation regarding the manufacture, import, distribution, etc. of medical devices. CLASSIFICATION OF MEDICAL DEVICES All medical devices require pre-market registration from KFDA before they can be manufactured locally or imported into Korea. There are two types of premarket licenses:i) pre-market approval for Class II, III, and IV devicesii) pre-market notification for Class I. Premarket requirements 1. Business License
2. Product License
3. Quality System regulation – KGMP audit and approval Submit applications to KFDA Regional Office in Form 1
GMP/GIP is also reviewed at the same time to approve a device business license application. Official time for review taken by KFDA is 25 days. Business License Product License There are two types of premarket product licenses:
Premarket notification for class I devices
Premarket approval for class II, III and IV devices Premarket notification for class I devices Option 2: Sequential Application Option 1: Package Application Timelines and Fees Quality System Regulation: Audit & Approval Class I medical devices require only Pre-Market Notification, which involves:
Classifying the device;
Providing Certificate of Free Sale; and
The submission of Form 5 (to be completed by Korean importer) including:
Local importer information (company name, address and device business license number;
local company representative and his/her resident registration number);
Trade name, product name and classification name of device;
Specifications of finished product;
Instructions and precautions for use;
Foreign manufacturers’ company name. Requirements for Class I Requirements for Class II, III & IV Class II, III and IV medical devices require Pre-Market Approval, which involves:
Classifying the device;
Providing Certificate of Free Sale;
Step 1 – Technical Review: Form 7, Medical Device Technical Documents Review Request including:
Local importer’s company name, address and device business license number; local company representative and his/her resident registration number;
Foreign manufacturer’s company name, address and country of manufacture;
Product, model, and classification names of device;
External appearance, internal structure, sizes;
Manufacturing methods; Effectiveness, performance and purpose of use;
Instructions and precautions for use;
Storage conditions, validity period;
Standards and test standards; and
Labeling. In addition to submitting a Form 7 to KFDA, Class II, III and IV devices require a cover page and an attachment with a description of each supporting document. These documents include:
Bench test reports;
Clinical trial reports;
Information on physical/chemical characteristics;
Information on electric/mechanical safety;
Information on biological safety;
Information on radiation safety;
Information on electromagnetic interference (EMI); and
Rationales and test reports to confirm safety and product performance. In addition these documents are required... Step 2 – Type Testing (mandatory for Class II, III and IV devices) Once the product passes Step 1, the technical review phase, it then must undergo type testing (i.e. a KFDA-authorized lab tests the product, or makes a determination that, based upon acceptable foreign data, the product does not require local testing in Korea).
Required information includes:
Candidate importer and manufacturer;
Necessary quantity; and
Name of test lab asked to carry out testing.
Typical test reports requested:
Performance Reports Step 3 – Obtain Product License Two types of product license: manufacturer and importer
Form 3 is required to receive certificate of product approval from KFDA. Other items include:
Copy of approved technical file;
Copy of approved type test;
List of facilities; and
Free Sale Certificate issued by government of country of manufacture Why Korean Market??? Medical Equipment Revenues, US$ Bn, 2009-2012 Summary & Conclusion Dealing with the Korean regulatory structure can be tricky and requires expertise on the ground. Communication and consultation with officials is necessary at many stages, and officials will not discuss applications in English. However, these are not reasons to stay away—but reasons to be deliberate and patient in entering this key Asian market.
The Korean Medical Device market has a lot of potential and hence an important area for business into the country as it ranks among the top 5 markets in Asia.