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Find usefull internet links provided for a quick and fast access to laws, regulations and guidelines. The links are intended for those, who are already familiar with the most common terms, abbreviations, as well as with the different authorities and institutions. For more details, please visit the knowledge page section about "§ Guidance".
Quick-Links to famous GMP related websites:
Quick-Links to other useful websites:
FDA Homepage www.fda.gov
FDA Organization https://www.fda.gov/AboutFDA/CentersOffices/default.htm
FDA cGMP Regulations https://www.fda.gov/…
Food Drug & Cosmetic Act, Title 21/Chapter 9 uscode.house.gov ...[1]
Code of Federal Regulation, CFR Title 21 accessdata.fda.gov or ecfr.gov
Guide to Inspections https://www.fda.gov/.../inspection-guides
Guidance General (search) fda.gov/.../Guidances/default.htm
Guidances Drugs - Newly Added and Withdrawn fda.gov/Drugs/.../default.htm
Guidances Biologics fda.gov/BiologicsBloodVaccines/.../default.htm
Guidance, Compliance, & Regulatory Information https://www.fda.gov/drugs/guidance..
cGMP Questions & Answers https://www.fda.gov/drugs/.../qa-cgmps
Compliance Manuals General fda.gov/iceci/compliancemanuals/default.htm
Compliance Policy Guides (CPG) fda.gov/.../CompliancePolicyGuidanceManual/default.htm
Compliance Program Guidance Manuals (CPGM) fda.gov/.../ComplianceProgramManual/default.htm
Manufacturing according GMP Overview fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/default.htm
Search for FDA Guidance Documents https://www.fda.gov/RegulatoryInformation/Guidances/default.htm...
FDA Dashboard - Firm/Supplier Evaluation Resources https://datadashboard.fda.gov/ora/fd/fser.htm
[1] A comparison to original FD&C Act chapter numbers you can find on FDA's website here
EMA homepage www.ema.europa.eu
EMA Quality Guidelines on Human Medicines www.ema.europa.eu/.../quality-guidelines
EMA Marketing Authorization https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation
EMA Certifying Medicinal Products http://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/certification-medicinal-products
EMA Requesting Certificates https://www.ema.europa.eu/…/requesting-certificates
EC Medicinal Products Homepage https://www.ema.europa.eu/en/homepage
EU Eudralex homepage ec.europa.eu/health/documents/eudralex_en
EU Eudralex Vol 4 GMP health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
EDQM (CEP & EP) https://www.edqm.eu
EDQM Documents & Guidelines www.edqm.eu/en/certification-policy-documents-guidelines
EDQM Certification https://www.edqm.eu/en/certification-policy-documents-guidelines
EDQM Inspection https://www.edqm.eu/en/inspection-programme-certification-159.html
EDQM Quality Management (QM) Guidelines https://www.edqm.eu/en/quality-management-qm-documents
HMA Heads of Medicines Agencies http://www.hma.eu
ZLG German Authority Committee https://www.zlg.de/en/
ZLG Quality Documents (German language) https://www.zlg.de/arzneimittel/deutschland/qualitaetssystem
National Medical Products Administration https://www.nmpa.gov.cn/
>> English Website https://english.nmpa.gov.cn/, https://english.nmpa.gov.cn/lawsandregulations.html
Center for Food and Drug Inspection of NMPA (also NATIONAL CENTER FOR VACCINE INSPECTION) https://www.cfdi.org.cn/cfdi/index
>> English Website https://www.cfdi.org.cn/cfdi/index_en
Center for Drug Evaluation, NMPA http://www.cde.org.cn
Center for Drug Reevaluation, NMPA (National Center for ADR monitoring) http://www.cdr-adr.org.cn
National Institutes for food and Drug Control (China National Institutes for Drug Control) https://www.nifdc.org.cn/nifdc/
NMPA-ICH Office http://www.cde.org.cn/ichWeb/index.jsp
ICH Guidelines (English version + Chinese translated version) https://www.cde.org.cn/ichWeb/guideIch/toGuideIch/1/0
Drug Administration Law of the People's Republic of China (2019 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html
>> English version (only summary) https://english.nmpa.gov.cn/2019-09/26/c_773012.htm, http://subsites.chinadaily.com.cn/nmpa/2019-08/26/c_409529.htm
Vaccine Administration Law of the People's Republic of China (2019 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190702121701506.html
>> English version (only summary) http://subsites.chinadaily.com.cn/nmpa/2019-08/09/c_395175.htm
Good Manufacturing Practice for Drugs (2010 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_d5e1dbaa8f284277a5f6c3e2fc840d00.html
>> English version (2010 Revision) http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390613.htm
Provisions for the Supervision and Administration of Drug Manufacturing (2020 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_65070d0ee03a4109ac831ee7b3cee51c.html
>> English version (2020 Revision) https://english.nmpa.gov.cn/2022-06/30/c_785630.htm
Provisions for Drug Registration (2020 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html
>> English version (2020 Revision) https://english.nmpa.gov.cn/2022-06/30/c_785628.htm, http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390615.htm
Provisions for Drug Recall (2022 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20221026164304199.html
>> English version (2007 Revision) http://subsites.chinadaily.com.cn/nmpa/2019-10/11/c_415401.htm
Provisions for Administration of Medical Device Recall (2017 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_2516c4771ace49d394f58d5619cba2ad.html
>> English version (2017 Revision) http://subsites.chinadaily.com.cn/nmpa/2019-10/11/c_415401.htm
Provisions for the Lot Release of Biological Products (2020 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_44550c0842eb4e848ec197cd5fb5f49a.html
>> English version (2020 Revision) https://english.nmpa.gov.cn/2022-06/30/c_785631_4.htm
Good Supply Practices for Drugs (2016 Revision) (GDP in China) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_bc07ffdb7a1c4e46be371ac5a4a65f9c.html
>> English version (2016 Revision) https://english.nmpa.gov.cn/2022-06/30/c_785622.htm
Good Laboratory Practices for Drugs (2017 Revision) http://www.cfdi.org.cn/resource/news/9196.html
Good Clinical Practices for Drugs (2020 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20200426162401243.html
Provisions for the Management of Radioactive Drugs (2022 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20230328171235176.html
Good Manufacturing Practices for Cellular Therapy Products (Trial) (2022 Revision) https://www.cfdi.org.cn/resource/news/14938.html
Provisions for Adverse Drug Reaction Reporting and Montoring (2011 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_eb5331517f7b4ed6b31b1bc5e816b88a.html
>> English version (2011 Revision) https://english.nmpa.gov.cn/2019-12/14/c_432227.htm
Good Manufacturing Practice for Excipients (2006 Revision) https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20060323010101520.html
YY/T 0287-2017 "Medical Devices -Quality Management Systems -
Requirements for Regulatory Purpose" (ISO 13485:2016, IDT) http://www.orac.hainan.gov.cn/xgfybz/YYT0287-2017.pdf
Provisions for Medical Device Registration and Filing (2021 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_568880e3ee344c45b38d073bba1c53ad.html
>> English version (2021 Revision) https://english.nmpa.gov.cn/2024-06/05/c_993242.htm
Rules for Classification of Medical Devices (2015 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_24dbff6e15494c9cb112ea15ed158001.html
>> English version (2015 Revision) http://subsites.chinadaily.com.cn/nmpa/2019-10/11/c_415411.htm
Provision for Supervision and Administration of Medical Device Manufacturing (2022 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_fc2666aec99f4b5d996faa13c4aed7a3.html
>> English version (2022 Revision) https://english.nmpa.gov.cn/2022-09/30/c_817459.htm
Provision for Registration and Filing of Health Food (2016 Revision) https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_b7b6a4ed9a5e4f4b8f8c4fc988cb3f01.html
MHRA Medicines and Healthcare products Regulatory Agency https://www.gov.uk/government/…regulatory-agency
MHR GMP and GDP website https://www.gov.uk/guidance/gmp-gdp
WHO guidelines, good practices, training material http://digicollection.org/whoqapharm/p/about/
Department of Essential Medicines and Health Products (EMP) www.who.int/medicines/en/
Quality Assurance (GMP) Guidelines www.who.int/.../quality_assurance/guidelines/en/
Technical Report Series https://extranet.who.int/prequal/medicines/who-technical-report-series
Prequalification Program for Manufacturer https://extranet.who.int/prequal/medicines/manufacturers
Codex Alimentarius (HACCP) http://www.fao.org/docrep/005/Y1579E/Y1579E00.htm
International Pharmacopoeia https://digicollections.net/phint/2022/index.html#p/home
Laboratory Biosafety Manual https://www.who.int/publications/i/item/9789240011311
PIC/S Homepage www.picscheme.org/en/picscheme
PIC/S Members www.picscheme.org/en/members
PIC/S GMP Guidelines www.picscheme.org/en/publications?tri=gmp
EC Medicinal Products Latest Updates https://health.ec.europa.eu/medicinal-products_en
EMA Latest News Updates https://www.ema.europa.eu/en/news-events/whats-new
BfArm - German Federal Institut for Drugs and Medical devices (EN) - https://www.bfarm.de/EN/News/_node.html
BfArm - German Federal Institut for Drugs and Medical devices (DE) - https://www.bfarm.de/DE/Aktuelles/_node.html
ECA European Compliance Academie - latest GMP News https://www.gmp-compliance.org/gmp-news/latest-gmp-news
Maas & Peither Publishing latest GMP News https://www.gmp-publishing.com/content/en/gmp-news/news-about-gmp-cgmp
> German Associations
Pharma Deutschland (former: BAH) https://www.pharmadeutschland.de/
BPI Bundesverband Pharmazeutische Industrie https://www.bpi.de/de/
VfA Verband forschender Arzneimittelhersteller https://www.vfa.de
SecurPharm German Medicines Verification Organisation https://www.securpharm.de/?lang=en
> US American Associations
PDA Parenteral Drug Association https://www.pda.org
PDA Technical Reports Overview https://www.pda.org/…/technical-reports
> European Associations
CEFIC European Chemical Industry Council http://www.cefic.org
APIC Active Pharmaceutical Ingredient Council https://www.apic.cefic.org
> International Associations
IPEC International Pharmaceutical Excipients Council https://www.ipec-europe.org/
ISPE International Sociaty for Pharmaceutical Engineering https://ispe.org/#
ISPE Listing of Regulatory Comments on New Guidelines https://ispe.org/initiatives/regulatory/commenting/ispe
Pharmacopoeia related Websites
US Pharmacopoeia https://www.uspnf.com
EU Pharmacopoeia (11th edition) https://www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition
Japanese Pharmacopoeia (17th edition) https://www.mhlw.go.jp/file/06...
WHO International Pharmacopoeia http://apps.who.int/phint/en/p/about/
Swiss Pharmacopoeia http://www.phhelv.ch
Audit & Certification related Websites
APIC Audit Programme https://www.api-compliance.org/home.html
EXiPACT Excipient Certification Scheme https://www.excipact.org
Rx-360 Supply Chain Auditing and Certification https://rx-360.org
TOP 200 Pharmaceutical Products Poster (University of Arizona) https://njardarson.lab.arizona.edu/content/...
ClinRegs Aggregating Clinical Research Regulations Around the Globe https://clinregs.niaid.nih.gov
NBC2 Northeast Biomanufacturing Center and Collaborative http://biomanufacturing.org