USP, FDA, ICH Flashcards
What are Pharmacopeias?
Pharmacopeias: monographs and books with uniform standards required to make a drug and ensure the drug qualities
United States Pharmacopeia (USP)
- 1820 the first USP was created as a system of quality control by physicians
The National Formulary (NF)
- 1888 National Formulary of Unofficial Preparations was published by pharmacists
- 1975 USPC purchased NF from APhA
- 1980 USP XX and NF XV – first combined compendium
USP-NF Revision
- 1830~1942 Committee renewed every 10 years
- 1942~2002: Every 5 years,
- After 2002: annually
Describe Drug Substances and Dosage forms Monographs
Drug Substances (USP Monographs)
Official title
Definition: Formula, structure, MW, chemical name, CAS number, Chemical purity
Cautionary statement
Packaging and storage
Quality standards: physical and chemical test and assay methods
Dosage forms (USP Monographs)
+ Preparation methods and quality standards
Pharmaceutical ingredients (excipients, NF Monographs)
US FDA & USP
1820, USP was founded by a group of practitioners to enforce an overall goal of “Good Pharmaceutical Care for All”
U.S. Pharmacopeial Convention is a non-profit organization
1906, both USP and NF standards were legally recognized under the Federal Food and Drug Act
1938, The Federal Food drug and Cosmetic Act further expanded on this by citing the USP-NF as the Official Compendia
The Standards published in the USP-NF are legally enforced by the FDA
USP and FDA collaborate with each-other to promote safe and effective standards of pharmaceutical care
The approved NDA by FDA which have developed initial standards will be adopted as new monographs by USP_NF
What are the US Federal Regulation?
- 1906 Food and Drug Act of 1906
- 1938 The Federal Food, Drug, and Cosmetic Act (NDA)
- 1952 Durham-Humphrey Amendments (Rx vs OTC)
- 1962 Kefauver-Harris Amendments (Require effectiveness for approval, GMP, INDA)
- 1970 Comprehensive Drug Abuse Prevention and Control Acts (Schedule)
- 1972 Drug Listing Act (NDC)
- 1984 Drug Price Competition and Patent Term Restoration Act (+ANDA for generics)
- 2010 Patient Protection and Affordable Care Act (+Biosimilars)
Describe the Food Drug and Cosmetic Act of 1938.
- Background: 1937 Elixir of Sulfanilamide was created by a reputable manufacturer using diethylene glycol as the solvent. Over 100 people died of diethylene glycol poisoning before the drug was pulled. This indicated that there was a necessity for proper formulation, and thorough pharmacological and toxicological testing of both active and inactive ingredients
- Created New Drug Application (NDA) format. – prohibited distribution of new drugs or drug products without filing a New Drug Application and FDA approval
- This act required pharmaceutical products to be safe for human use but did NOT require them to be efficacious
What is Kefauver-Harris Amendement of 1962?
Background: by 1962, Thalidomide caused birth defects in thousands of babies in Europe. Fortunately, thalidomide was denied by FDA
Require INDA before any clinical use on human (clinical trial)
Often called “Drug Efficacy Amendment“ – Started to require approval of effectiveness
What is the drug price compeition and patent term restoration Act of 1984?
- Informally known as the “Hatch-Waxman Act”
- Established the system of generic drugs in the US
- Generic drugs can be filed through Abbreviated New Drug Applications (ANDAs)
- FDA mainly review drug’s bioavailability and CMC standards for approval
What is the International Conference on Harmonisation (ICH)?
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human
First meeting: 1991— Work towards bringing together the regulatory requirements with a long term goal of establishing a uniform set of drug registration standards in these areas
3 regions: Europe, Japan and the USA
Joined by both regulatory agencies and industry
Focus on quality, safety and efficacy
www.ich.org
