Contains a very useful page of web links for other regulatory
bodies worldwide
The main responsibility of the EMEA, is the protection and promotion of public and animal
health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation
and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of
the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners,
reinforcing the EU contribution to global harmonisation.
You may be familiar with FDA's cGMP notes, where the Agency publishes current questions
and answers regarding GMP compliance. Now, EMEA has also published at least one q-and-a session.
This is a useful source of information on GMP requirements for European markets
ICH Website
This is the web-site of The International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH is a unique project that brings together
the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three
regions to discuss scientific and technical aspects of product registration.
The MHRA is the UK’s
regulatory agency. Here you can access information on UK regulatory requirements,
current issues, adverse events reporting, and MHRA publications
An MHRA site focussing specifically on medical devices
This
section of the MHRA site consists of information about the work of the Medicines sector of the MHRA. It will provide you with
regulatory information, MHRA publications and MAIL publications
Risk- based cGMPs
In August 2002, the Food and Drug Administration (FDA
or the Agency) announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the
21st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality —
to bring a 21st century focus to this critical FDA responsibility. The initiative, which this final report
describes in detail, was intended to modernize FDA’s regulation of pharmaceutical quality for veterinary and human drugs
and select human biological products such as vaccines
Pharma IQ Community
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Use London Underground
Use Frixo for Road/Motorway & Traffic Reports
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FDA Forms Distribution Page for Center for Drug Evaluation and Research (CDER)
This very useful web address, provides access to all the forms you need to use for FDA in a variety of formats.
Provides links to
variety of information regarding US regulations; inspecton findings, warning letters etc.
Through this site
you can access drug information, the CDER calendar , regulatory guidance and CDER
Links to
a printable (pdf file) list of the FDA’s guidance documents
From time to time people ask
us where they can find inspection documents issued by the FDA. The Agency published the most frequently requested inspection
documents on a regular basis.
Provides a list of all recent 483s issued by FDA
FDA Searchable Site for CFR 21
FDA searchable site for CFR 21 Part 211
Databases on the FDA website
The search engine on the FDA Website will not find information
that is in the databases that make up a large part of the site. Those databases can be accessed separately, using the links
below. Following each link is a brief description of the database.
You can view PS 9000 and PS 9004
and many other quality standards via this site
Through this site you can access a variety of information on Quality Management and other IQA issues
The Education and Professional Development area includes information on QPs and list of current QPS in the
UK.
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