A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

 

 

World Health Organization (WHO) [7]
When diplomats met to form the United Nations in 1945, one of the things they discussed was setting up a global health organization.
Constitution of the World Health Organization : The Constitution was adopted by the International Health Conference held in New York from 19 June to 22 July 1946, signed on 22 July 1946 by the representatives of 61 States and entered into force on 7 April 1948 - a date we now celebrate every year as World Health Day.

Pan American Health Organization (PAHO)[8]
The Pan American Health Organization (PAHO), founded in 1902, is the world’s oldest international public health agency. It provides technical cooperation and mobilizes partnerships to improve health and quality of life in the countries of the Americas. PAHO is the specialized health agency of the Inter-American System and serves as the Regional Office for the Americas of the World Health Organization (WHO). Together with WHO, PAHO is a member of the United Nations system.

World Trade Organization (WTO) [9]
The WTO is a rules-based, member-driven organization - all decisions are made by the member governments, and the rules are the outcome of negotiations among members.
International Conference on Harmonization (ICH) [10]
ICH’s mission is to make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.
Launched in 1990, ICH is a unique undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States.
Regulatory harmonization offers many direct benefits to both regulatory authorities and the pharmaceutical industry with beneficial impact for the protection of public health.

PROGRESS IN INTERNATIONAL HARMONIZATION
There have been enormous changes in the technical and scientific requirements for the dossier, as the work of the ICH has continued to devise and approve new guidelines in the categories of Quality, Safety, Efficacy, and Multidisciplinary. The CTD harmonized structure and modular format for new medicinal product registration files that were adopted in San Diego, is now the obligatory format in the European Union (EU), Japan, Canada, Switzerland, and Australia. It is the recommended format in the United States.

THE CTD—A COMMON FORMAT, NOT A HARMONIZED CONTENT FOR SUBMISSIONS
Enormous efforts have been expended by the staffs of the regulatory agencies and the pharmaceutical industry in the work of the ICH, and this has achieved a remarkable degree of harmonization in many scientific and technical areas of the dossier. Despite this there are still national differences in the content of submissions not only in Module 1, the administrative and prescribing information, but also in other areas of the dossier. These arise from differences in regulatory practice and procedures, different practices of medicine and pharmacy, and differences in access to diagnostic and therapeutic procedures. We are, however, still far from a genuinely global single registration dossier.

INCREASED COOPERATION BETWEEN AGENCIES BASED ON ICH
Mutual Recognition Agreements between agencies in relation to Good Manufacturing Practice (GMP) are in operation between the EU and Canada, Australia, New Zealand, Switzerland, and Japan. Arrangements exist between many countries (including the ICH members) for exchange of pharmacovigilance and defect information.
The confidentiality arrangements between the EU and the FDA now allow for exchange of information on legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures, and post-marketing surveillance. In September 2004, the European Medicines Agency (EMEA) and the Food and Drugs Administration (FDA) instituted a pilot program of parallel scientific advice meetings for sponsors to obtain advice on scientific issues during the development phase of new medicinal products. Orphan indication products and pediatric products have been targeted in particular. Bilateral and trilateral collaboration has increased in 2008. Health Canada has agreed to exchange information with the European Commission and EMEA about the authorization and safety of drugs. Canada and Australia have started their parallel review project for biologicals (originally launched in 2006). All of this has only been possible based on the prior work that has been done in harmonization of regulatory requirements and in the development of the CTD format of the dossier in ICH.

SPREADING THE ICH MESSAGE—THE ICH GLOBAL COOPERATION GROUP
The ICH-affiliated and other developed countries, which have adopted the CTD format (the United States, EU, Japan, Canada, Switzerland, and Australia), comprise in total approximately 15% of the current (2008) world population of 6650 million people. The ICH Global Cooperation Group (GCG) was formed on March 11, 1999 as a subcommittee of the ICH Steering Committee. Its purpose is to make information available on ICH, ICH activities, and any ICH guideline to a wider group of countries.

Regional Harmonization Initiatives
A number of regional harmonization initiatives (RHIs) have been set up where a geographic grouping of countries harmonizes technical and scientific requirements and in some cases the format of submissions for member countries. These groups have been invited to designate permanent representatives to the GCG. They currently comprise:
Asia-Pacific Economic Cooperation (APEC): 21 countries in the Asia-Pacific region.
Association of Southeast Asian Nations (ASEAN): Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
Gulf Cooperation Countries (GCC): Saudi Arabia, Kuwait, United Arab Emirates, Oman, Bahrain, Qatar and Yemen.
Pan American Network on Drug Regulatory Harmonisation (PANDRH): Argentina, Barbados, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Guatemala, Jamaica, Mexico, Panama, Trinidad and Tobago and Venezuela.
South African Development Community (SADC): Angola, Botswana, Democratic Republic of Congo, Lesotho, Malawi, Mauritius, Madagascar, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.

The regional groups review the applicability of the ICH guidelines in their own specific countries. Particular topics of interest include the ICH stability guideline, GMP guidances, requirements for bioavailability and bioequivalence studies, clinical trials, export/import of medicines, traditional medicines, and market surveillance.

The following are the various regions as per regulatory guidelines having CTD structure / format for registration product-[11-13]
* ASEAN Region  (ACTD Format): Brunei, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
* African Region (CTD Format): Nigeria, Kenya, South Africa, Zimbabwe, Tanzania, Ethiopia, Namibia, & Mauritius.
* CIS Region (CTD Format) (country specific resemble to CTD): Maldova, Russia, Ukraine, Georgia, Kazakhstan, Uzbekistan.
* WHO & India (CTD Format)
* LATAM region (Country specific): Mexico, Panama, Venezuela, Chile, Costa-Rica, Brazil, Dominican Republic & Jamaica.
* GCC Region (CTD Format) and Australia (ICH-CTD Format)

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