Drug Regulatory AffairsPDF

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Compiled by-Shmmon Ahmad M.Pharma Q.A Chandigarh Group of Colleges Landra MohaliPunjab Indiaemail- shmmongmail.com 28/12/2012 DRUG APPROVAL Increasing number of Indian pharmaceutical companies have been getting international regulatory approvals for their plants from agencies like USFDA USA MHRA UK TGA Australia MCC South Africa Health Canada etc. India has the largest number of USFDA-approved plants for generic manufacture. Considering that the pharmaceutical industry involves sophisticated technology and stringent "Good Manufacturing Practice GMP requirements major share of Indian Pharma exports going to highly developed western countries bears testimony to not only the excellent quality of Indian pharmaceuticals but also its price competitiveness. More than 50 per cent share of exports is by way of dosage forms. Indian companies are now seeking more Abbreviated New Drug Approvals ANDAs in USA in specialized segments like anti-infective cardio vascular and central nervous system groups. INTERNATIONAL CONFERENCE OF DRUG REGULATORY AUTHORITIES “The International Conference of Drug Regulatory Authorities ICDRAs provide drug regulatory authorities of WHO Member States with a forum to meet and discuss ways to strengthen collaborationhelp”. The ICDRAs have been instrumental in guiding regulatory authorities WHO and interested stake holders and in determining priorities for action in national and international regulation of medicines vaccines biomedicines and herbals. The conferences have been held since 1980 with the aim of promoting exchange of information and collaborative approaches to issues of common concern. As a platform established to develop international consensus the ICDRA continues to be an important tool for WHO and drug regulatory authorities in their efforts to harmonize regulation and improve the safety efficacy and quality of medicines. Regulatory authorities are continually faced with new issues - such as globalization and extension of free trade - while increased responsibilities from expansion of the market and the improvement and sophistication of products place heavy demands on regulatory systems and knowledge bases. The development of cutting edge technologies and health care techniques and extensive use of the Internet impose further complex challenges.

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The ICDRA programme is developed by a planning committee of representative drug regulators. Topics discussed during the four days of the ICDRA may include quality issues herbal medicines homeopathy regulatory reform medicines safety counterfeiting access regulation of clinical trials harmonization new technologies and e-commerce. Recommendations are proposed for action among agencies WHO and related institutions. INTERNATIONAL CONFERENCE OF HARMONISATION ICH Regulatory authorities of Europe Japan and the United States experts from the pharmaceutical industry in the three regions discuss •Scientific and technical aspects of product registration. •Recommendations on harmonisation in the interpretation and application of technical guidelines requirements for product registration The need to duplicate the testing carried out during theresearch and development of new medicines. MHRA The Medicines and Healthcare products Regulatory Agency MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products working with UK blood services healthcare providers and other relevant organisations to improve blood quality and safety. Medicines Whether it is a medicine you buy or one prescribed for you as part of a course of treatment it is reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety quality and efficacy. OECD The mission of the Organisation For Economic Co-Operation And Development OECD is to promote policies that will improve the economic and social well-being of people around the world. The OECD provides a forum in which governments can work together to share experiences and seek solutions to common problems. We work with governments to understand what drives economic social and environmental change. We measure productivity and global flows of trade and investment. We analyse and compare data to

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predict future trends. We set international standards on a wide range of things from agriculture and tax to the safety of chemicals. We look too at issues that directly affect the lives of ordinary people like how much they pay in taxes and social security and how much leisure time they can take. We compare how different countries’ school systems are readying their young people for modern life and how different countries’ pension systems will look after their citizens in

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