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A selection of labeling-related links for labeling, regulatory and pharmacovigilance professionals.
Click on the headings to go to the link section.
- General
- European Union - "Centralized Products"
- European Union - Core SPCs
- European Union - "MRP and DCP Products"
- European Union - Nationally Approved Products
- Switzerland
- US Labeling
- New Zealand
- Japan
- USA
- European Union
- Japan
- Canada
- Switzerland
- CIOMS
- ICH
- NCI terminology browser
- MedDRA MSSO (best practices for using MedDRA in labeling)
- List of error-prone abbreviations (ISMP/FDA)
- WHO's Pharmaceutical Products site
A collection of links to websites that explain the clinical meaning adverse reactions
Any suggestions for links to more hard-to-find materials? Please send us an email.
Focus is on freely accessible regulated healthcare professional information
Be aware that there may be a significant lag time between a labeling change and the publication of revised labeling at the websites listed below.
This means:
Do not use these links to retrieve product information in order to make medical/therapeutic decisions. Many of the documents retrieved through these links will be outdated and might miss important information on the safe and effective use of the medicine.
If you want to be sure to get the most current product information, contact the product's manufacturer.
General
One of the best sources of labeling are the websites of pharmaceutical manufacturers.
If you want to be sure to get the most current product information, contact the product's manufacturer by phone or email.
European Union - "Centralized Products"
EMEA's Human Medicines website
EMEA's Human Medicines website is currently (Nov 2007) the best source for information on products that have been approved according to the centralized procedure.
Go to the product's EPAR.
Under Product Information click EN to retrieve the English version of the SPC, Package Leaflet and other elements of EU labeling.
The EPAR itself contains valuable information on the background of the product's labeling, including the reasons for labeling changes.
EudraPharm
EudraPharm, a database of medicinal products for human or veterinary use that have been authorized in the European Union (EU) and the European Economic Area (EEA), is under construction.
Currently (Nov 2007), it contains only information on "Centralized products".
It does not provide links to public assessment reports (EPARs).
At this time, EMEA's Human Medicines website apepars to be the better choice.
EMEA's What's New
EMEA's What's New web page contains the agency's regulatory news and press releases on safety issues.
European Union - Core SPCs
A number of Core SPCs can be found on the website of the European Union's "Heads of Medicines Agencies".
Core SPCs for blood products, including biotech alternatives, can be found at the EMEA website under Scientific Guidelines for Human Medicinal Products.
European Union - "MRP and DCP Products"
The European Union's "Heads of Medicines Agencies" contains a searchable database (MRI Product Index) of medicines approved in EU member states according to the Mutual Recognition procedure.
The site allows you
- to search for individual products (many search result pages have links to labeling) or
- to create a list of all products in the database that have links to the SPC, to the Package Leaflet or to an assessment report.
European Union - Nationally Approved Products
National agency websites
The European Union's "Heads of Medicines Agencies" website contains a site with links to the national regulatory authorities of the EU member states.
Many of these national agency website contain links to the labeling of products approved in their territory.
Medicines.org.uk
A great source of UK labeling is the medicines.org.uk website.
It allows to search and retrieve labeling for products that have a national registration in the UK, have been approved in the UK through the mutual recognition procedure, or have central EU approval. Click the eMC link.
Switzerland
Use the search function in Switzerland's electronic Documed compendium.
US Labeling
Daily Med
The Daily Med website of the National Library of Medicine (NLM) provides a large (and still growing) number of US Prescribing Information texts (with appended FDA-approved Patient Labeling, where available) in SPL format.
The texts represent the so called "content of labeling".
Note: The tables with product data elements at the end of a SPL document are not part of the official content of labeling.
The Daily Med site contains also a link (bottom of site) to other medicines information provided by NLM.
The Daily Med site will evolve into a reliable source for most current labeling.
Drugs @ FDA
FDA's website "Drugs @ FDA" provides approved labeling (incomplete; only approved labels, ie, not necessarily the current labeling in use) as well as limited regulatory background information for labeling changes, including approval history (incomplete).
The link "Label Information" as at the individual NDA/BLA/ANDA level.
Index to Drug-Specific Information
FDA's website "Index to Drug-Specific Information" provides links to "active safety alerts".
These are released by FDA when there is, for example, "emerging safety information" that FDA wants to communicate without necessarily asking for a labeling change (at that time).
MedWatch
This MedWatch website contains information about safety-related US labeling changes, sorted by year and month.
New Zealand
Medsafe, New Zealand's regulatory agency, offers an online search for health professionals and consumer information.
Japan
Japan Pharmaceutical Reference
The Japan Pharmaceutical Manufacturers Association maintains a website (Japan Pharmaceutical Reference; JPR) with English translations of a large number of Japanese prescribing information texts.
Safety labeling updates
PMDA offers chronological lists with brief descriptions of safety labeling updates in English (updates to the Precautions section, which in Japan includes most of the safety information).
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The following links point to the official websites of the content providers. We can not be sure that these providers replace outdated material by new content using the exact same URL. This means: Before using any of this content for regulatory decision making, verify that it is still current.
Proper regulatory practice requires familiarity with additional laws, regulations, guidelines, standards and regulatory expectations.
USA
US labeling regulations can be searched and obtained here. You need to know what to look for.
Information related to the new prescribing information format (with Highlights) has been collated at this special FDA website.
This site contains a link to a so called "Sample Tool Illustrating the Format for Highlights and Contents". This MS Word template can be used to check if a draft Highlights section meets FDA's half page standard; type your draft Highlights in the template (don't tamper with the formatting!), print it on a US letter size page, fold the page in half and check if the Highlights text reaches below the folding line.
CDER guidance documents are available from this website. Click on Labeling for labeling-specific guidance documents (draft and final). Note that many guidance documents in other categories contain topic-specific labeling guidance.
CBER Guidance documents are here.
This link points to FDA's 2008 proposed rule for pregancy and lactation labeling.
Link to FDA's SPL Resources website.
The SPL website of the HL7 Structured Product Labeling Working Group. Under construction - no content yet (Nov 2007).
"Proposed CBE Rule": Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices. Jan 2008
Food and Drug Administration Amendments Act (FDAAA) (Sep 2007)
European Union
The QRD group provides a convenient portal to labeling-specific guidelines, QRD reference documents and templates.
An annotated QRD template for SPC, labelling and package leaflet for the Mutual Recognition and Decentralized Procedure is found here on the Heads of Medicines Agencies website.
The December 2007 draft SPC guideline can be found here: Clean version; redlined version.
Our comments on the draft, sent to EMEA, are here.
The EudraLex website provides links to the EU pharmaceutical "regulations". Of importance for human medicines are volumes 1, 2, 3, 9 and 10. The following guidelines are found in Volume 2C:
- Guideline on the packaging information of medicinal products for human use authorised by the Community
- Guideline on the readability of the label and package leaflet of medicinal product for human use
- Guidance concerning consultation with target patient groups for the package leaflet
Other labeling-specific guidelines (Core SPCs) and topic-specific guidelines that contain, among other guidance, labeling-specific elements are found in Volume 3.
Volume 9A is about Pharmacovigilance and contains information about the use of reference safety information/CCDS for periodic reporting, as well as information on the creation of reference information for generics (more specific guidelines for generics are underway; Nov 2007).
Be careful not to confuse definitions and rules that apply to regulatory reporting with the rules for safety labeling.
Information about PIM is found here.
Link to the Commission's proposed Pharmacovigilance Strategy: Public consultation on draft legislative proposals (5 December 2007 – 1 February 2008). The consultation document contains a proposal to highlight the most important safety information in the SPC and Package Leaflet.
Pharmiceutics' comments on the labeling proposals are available here.
Japan
The Japan Pharmaceutical Manufacturers Association provides an English-language overview of Japanese pharmaceutical regulations. The document, called "Pharmaceutical Administration and Regulations in Japan", contains a relatively detailed (but not complete) section on labeling.
English translations of the labeling regulations (in particular PAB Notification No. 606 and PAB Notification No. 607) are currently (Nov 2007) not available on the web.
Canada
This is a link to the Canadian Product Monograph Guidance.
Switzerland
Link to the Siwss guideline for prescribing information and patient information.
CIOMS
The CIOMS III/V report is out of print. An electronic version is available in IDRAC.
All other reports can be ordered from CIOMS. Send an email to the address listed here.
ICH
All ICH guidelines can be found here. Clinical safety-related guidelines are found under "E".
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NCI Terminology Browser
The US National Cancer Institute offers a website, the NCI Terminology Browser, that gives password-free access to various terminologies, including SNOMED CT, LOINC, VA NDFRT, HL7 terminology, and MedDRA. Note that the use of the MedDRA module requires an active MedDRA license.
MedDRA MSSO
MedDRA: The MSSO maintains a website with a lot of useful information. With regards to labeling, the most important document is "MedDRA and Product Labeling: Best Practices Recommendations". On the MSSO's website, click Documentation Library.
Error-Prone Abbreviations
ISMP and FDA campaign to eliminate use of error-prone abbreviations. Website contains link to error prone abbreviations.
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WHO's Pharmaceutical Products website
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