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Compiled by-Shmmon Ahmad,, M.Pharma (Q.A) Chandigarh Group of Colleges, Landra, Mohali(Punjab India)emailshmmon@gmail.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 collaboration(help)”.
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.
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
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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Drug Regulatory Affairs pdf

  • 1. Compiled by-Shmmon Ahmad,, M.Pharma (Q.A) Chandigarh Group of Colleges, Landra, Mohali(Punjab India)emailshmmon@gmail.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 collaboration(help)”. 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.
  • 2. 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
  • 3. 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