Innovation in medicines - European Medicines Agency

Guidance and Reference Materials
EPA Form 3540-01: Notice of Arrival of pesticides and devices
How to Register a Pesticide – A Guide for Applicants New to the Process | US EPA
This web page provides resources to guide someone new to the pesticide registration process. It includes links to web pages where you can find more information as you get started.
Revisions regarding Determination of "Minor Use" pesticide product registrations under FIFRA ~Regulations.gov
2018 March
TSG Consulting
Global Regulatory Consulting
Pesticide Registration - main page | US EPA
******!!!!***This site provides resources for an individual or company wanting to register a pesticide active ingredient or pesticide product in the United States. Features: a manual (blue book), other guidance, and coordinated lists of requirements by pesticide type.
Electronic Code of Federal Regulations (eCFR)
******!!!!**** TITLE 40—Protection of Environment
CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY
SUBCHAPTER E—PESTICIDE PROGRAMS
Pesticide Registration Manual: Chapter 1 - Overview of Requirements for Pesticide Registration and Registrant Obligations | US EPA
Definitions: "Intent: ... The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise):
--that the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or
that the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or the substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or the person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for pesticidal purpose." "Active ingredient (A.I.) – Any substance... that will prevent, destroy, repel or mitigate any pest" "Pests – This term means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the [Agency] declares to be a pest" "Where a product label directs the user to add a particular adjuvant before use, the registering division will treat that adjuvant as if it were an "other ingredient""
Enforcement and Compliance - Can a foreign establishment now submit their own establishment report, or does an authorized agent still need to do that? ~US EPA
- - YES, foreign establishments can submit their own establishment report to EPA
National List of Active EPA-Registered Foreign and Domestic Pesticide and/or Device-Producing Establishments | US EPA
The information consists of the national list of all FIFRA Section 7 EPA-registered establishments in the Section Seven Tracking System (SSTS).
COMPLIANCE ADVISORY: What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19 ~US EPA
Jan 2021
Policy Implications of the Orphan Drug Designation for Remdesivir to Treat COVID-19
This Viewpoint highlights loopholes in US orphan drug policy as exemplified by the use of remdesivir to treat coronavirus disease 2019.
Overview of Drug Regulations ~FDA
Rulemaking on OTC drugs, monographs, etc. ~Federal Register: 55 Fed. Reg. 20261 (May 16, 1990).
1990
Launching An OTC Drug Product In The US 2021
Although the FDA doesn't require pre-approval for launching an OTC drug product in the US, there are still strict requirements to launch it legally.
Suggestions for Applicants on Information Considered when Evaluating Benefits of New Conventional Active Ingredients/Significant New Use Site Requests ~EPA
****!!!**** {This info is specific to traditional pesticides, but concepts may be extremely valuable when promoting new uses for chlorine dioxide}
1. A list of the use site(s)...
2. Expected use patterns for each site, including application timing or application method(s);
3. A summary of target pest(s) in the context of the use site, including the type and magnitude of damage caused by the main target pest(s); the frequency of occurrence; timing of occurrence; and any geographic or regional differences that may exist;
4. A summary of registered pesticides or other methods used to control the pest;
5. A comparison of the new pesticide to the current standard control methods and a discussion of how the new pesticide will benefit growers. Potential advantages that can lead to greater user (i.e. grower or producer [or other business or individual consumer) flexibility, better outcomes or lower costs include, but are not limited to:
• a new mode/mechanism of action for that site to facilitate resistance management;
• facilitating integrated pest management (IPM), including specificity against targeted
pests;
• providing equivalent or better efficacy or performance or improving pest [including pathogens] or crop [or other desired beneficial results] management compared to what is currently registered and available in the
marketplace.
Test Guidelines for Pesticide Data Requirements | US EPA
In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product.
Final Monograph for OTC Nasal Decongestant Drug Products ~FDA
1994
Over-the-Counter (OTC) Medicines Standards | USP
"ensure OTC manufacturers have the flexibility to innovate, improve and meet the challenges of developing and sustaining current monographs."
Data Requirements for Pesticide Registration | US EPA
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Guidance for Identifying, Selecting and Evaluating Open Literature Studies | US EPA
This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.
Small Molecule API CDMO: A Capital Intensive Business?
Exploring small molecule API market trends.
Five Signs Of An Effective CDMO (contract development and manufacturing organization) Partnership
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Waving Goodbye To Human Clinical Trials In A Post-COVID Landscape
Exploring the untapped potential presented by current biowaiver regulations.
21 CFR 173.300 - Chlorine dioxide. - Document in Context - CFR-2010-title21-vol3-sec173-300
Official Publications from the U.S. Government Publishing Office.
Modification to Secondary Direct Food Additives Permitted in Food for Human Consumption ~FDA
"The Food and Drug Administration (FDA) is amending the food additive regulations to permit the manufacture of chlorine dioxide by
electrolysis of an aqueous solution of sodium chlorite. This action is in response to a petition filed by Vulcan Chemicals."
Facts About the Current Good Manufacturing Practices (CGMPs) ~FDA
"help to establish the foundation for quality pharmaceuticals through regulatory standards."
CDER Small Business and Industry Assistance: Import and Export of Human Drugs and Biologics ~FDA
CDER Small Business and Industry Assistance: Import and Export of Human Drugs and Biologics
Over-the-Counter OTC | Nonprescription Drugs ~FDA
FDA regulates over-the-counter monograph drugs
Over-the-Counter (OTC) Drug Monograph Process
The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972.