FDA Title 21 CFR Parts
ICH Titles
EU & Canadian Titles
1 - General enforcement regulations
ICH
Q1A (R2) - Stability Testing of New Drug Substances and
Products
2 - General administrative rulings and decisions
- Photostability
Testing of New Drug Substances and Products
3 - Product jurisdiction
- Stability
Testing for New Dosage Forms
5 - Organization
- Bracketing and
Matrixing Designs for Stability Testing of New Drug
Substances and Products
7 - Enforcement policy
- Evaluation of
Stability Data
10 - Administrative practices and procedures
Q1F Stability Data Package for Registration Applications in
Climatic Zones III and IV
11 - Electronic records; electronic signatures
Q2(R1) New title: Validation of Analytical Procedures: Text
and Methodology
11+ - 11
with Preambles
Q2A
11+ - 11
Spanish
Q3A(R2) Impurities in New Drug Substances
12 - Formal evidentiary public hearing
Q3B(R2) Impurities in New Drug Products
13 - Public hearing before a public board of inquiry
14 - Public hearing before a public advisory committee
15 - Public hearing before the Commissioner
16 - Regulatory hearing before the Food and Drug
Administration
17 - Civil money penalties hearings
19 - Standards of conduct and conflicts of interest
20 - Public information
21 - Protection of privacy
25 - Environmental impact considerations
26 - Mutual recognition of pharmaceutical good manufacturing
practice reports, medical device quality system audit
reports, and certain medical device product evaluation
reports: United States and The European Community
50 - Protection of human subjects
-
54 - Financial disclosure by clinical investigators
-
56 - Institutional Review Boards
ICH Q7A
-
58 - Good laboratory practice for nonclinical laboratory
studies
-
60 - Patent term restoration
-
70 - Color additives
-
71 - Color additive petitions
ICH E2B
-
73 - Listing of color additives exempt from certification
-
74 - Listing of color additives subject to certification
-
80 - Color additive certification
-
81 - General specifications and general restrictions for
provisional color additives for use in foods, drugs, and
cosmetics
-
82 - Listing of certified provisionally listed colors and
specifications
-
99 - Dissemination of information on unapproved/new uses for
marketed drugs, biologics, and devices
100 - General
101 - Food labeling
102 - Common or usual name for nonstandardized foods
104 - Nutritional quality guidelines for foods
105 - Foods for special dietary use
106 - Infant formula quality control procedures
107 - Infant formula
108 - Emergency permit control
109 - Unavoidable contaminants in food for human consumption and
food-packaging material
110 - Current good manufacturing practice in manufacturing,
packing, or holding human food
110+ - 110
Spanish
111 - 111 Good Manufacturing Practices for Dietary
Supplement
113 - Thermally processed low-acid foods packaged in
hermetically sealed containers
114 - Acidified foods
115 - Shell eggs
119 - Dietary supplements that present a significant or
unreasonable risk
120 - Hazard Analysis and Critical Control Point (HACCP)
systems
123 - Fish and fishery products
129 - Processing and bottling of bottled drinking water
130 - Food standards: General
131 - Milk and cream
133 - Cheeses and related cheese products
135 - Frozen desserts
136 - Bakery products
137 - Cereal flours and related products
139 - Macaroni and noodle products
145 - Canned fruits
146 - Canned fruit juices
150 - Fruit butters, jellies, preserves, and related products
152 - Fruit pies
155 - Canned vegetables
156 - Vegetable juices
158 - Frozen vegetables
160 - Eggs and egg products
161 - Fish and shellfish
163 - Cacao products
164 - Tree nut and peanut products
165 - Beverages
166 - Margarine
168 - Sweeteners and table syrups
169 - Food dressings and flavorings
170 - Food additives
171 - Food additive petitions
172 - Food additives permitted for direct addition to food for
human consumption
173 - Secondary direct food additives permitted in food for
human consumption
174 - Indirect food additives: General
175 - Indirect food additives: Adhesives and components of
coatings
176 - Indirect food additives: Paper and paperboard components
177 - Indirect food additives: Polymers
178 - Indirect food additives: Adjuvants, production aids, and
sanitizers
179 - Irradiation in the production, processing and handling of
food
180 - Food additives permitted in food or in contact with food
on an interim basis pending additional study
181 - Prior-sanctioned food ingredients
182 - Substances generally recognized as safe
184 - Direct food substances affirmed as generally recognized as
safe
186 - Indirect food substances affirmed as generally recognized
as safe
189 - Substances prohibited from use in human food
190 - Dietary supplements
200 - General
201 - Labeling
202 - Prescription drug advertising
203 - Prescription drug marketing
205 - Guidelines for State licensing of wholesale prescription
drug distributors
206 - Imprinting of solid oral dosage form drug products for
human use
207 - Registration of producers of drugs and listing of drugs in
commercial distribution
208 - Medication Guides for prescription drug products
210/211 - Current good manufacturing practice in manufacturing,
processing, packing, or holding of drugs; general
210/211 -
210/211 Spanish
210/211 -
210/211 with Keyword Index
210/211 -
210/211 with Preambles
216 - Pharmacy compounding
225 - Current good manufacturing practice for medicated feeds
226 - Current good manufacturing practice for Type A medicated
articles
250 - Special requirements for specific human drugs
290 - Controlled drugs
299 - Drugs; official names and established names
300 - General
310 - New drugs
312 - Investigational new drug application
314 - Applications for FDA approval to market a new drug
315 - Diagnostic radiopharmaceuticals
316 - Orphan drugs
320 - Bioavailability and bioequivalence requirements
328 - Over-the-counter drug products intended for oral ingestion
that contain alcohol
330 - Over-the-counter (OTC) human drugs which are generally
recognized as safe and effective and not misbranded
331 - Antacid products for over-the-counter (OTC) human use
332 - Antiflatulent products for over-the-counter human use
333 - Topical antimicrobial drug products for over-the-counter
human use
335 - Antidiarrheal drug products for over-the-counter human
use
336 - Antiemetic drug products for over-the-counter human use
338 - Nighttime sleep-aid drug products for over-the-counter
human use
340 - Stimulant drug products for over-the-counter human use
341 - Cold, cough, allergy, bronchodilator, and antiasthmatic
drug products for over-the-counter human use
343 - Internal analgesic, antipyretic, and antirheumatic drug
products for over-the-counter human use
344 - Topical OTIC drug products for over-the-counter human
use
346 - Anorectal drug products for over-the-counter human use
347 - Skin protectant drug products for over-the-counter human
use
348 - External analgesic drug products for over-the-counter
human use
349 - Ophthalmic drug products for over-the-counter human use
350 - Antiperspirant drug products for over-the-counter human
use
352 - Sunscreen drug products for over-the-counter human use
[stayed indefinitely]
355 - Anticaries drug products for over-the-counter human use
357 - Miscellaneous internal drug products for over-the-counter
human use
358 - Miscellaneous external drug products for over-the-counter
human use
361 - Prescription drugs for human use generally recognized as
safe and effective and not misbranded: Drugs used in
research
369 - Interpretative statements re warnings on drugs and devices
for over-the-counter sale
500 - General
501 - Animal food labeling
502 - Common or usual names for nonstandardized animal foods
509 - Unavoidable contaminants in animal food and food-packaging
material
510 - New animal drugs
511 - New animal drugs for investigational use
514 - New animal drug applications
515 - Medicated feed mill license
520 - Oral dosage form new animal drugs
522 - Implantation or injectable dosage form new animal drugs
524 - Ophthalmic and topical dosage form new animal drugs
526 - Intramammary dosage forms
529 - Certain other dosage form new animal drugs
530 - Extralabel drug use in animals
556 - Tolerances for residues of new animal drugs in food
558 - New animal drugs for use in animal feeds
564 - [Reserved]
570 - Food additives
571 - Food additive petitions
573 - Food additives permitted in feed and drinking water of
animals
