Manufacturing authorization and product registration
MANUFACTURING AUTHORIZATION AND PRODUCT REGISTRATIONThe federal food, drug and cosmetic act prohibitthe shipment of a new drug that is not coveredby an approved new drug application.
A drug may be considered new because of its composition, its use, its dosage or its dosage form. It can readily be understood that a drug that contains active ingredients a new chemical entity or proportion of active ingredients or
combination of active ingredients or A drug’s recommended new use or change in recommended dosage, dosage form or route of administration also can cause it to be considered a new drug.
Investigational New Drug After its synthesis, a new chemical entity is normally subjected to a screening process which involves initial testing of the drug in a small number of animals of different species ( usually three) and microbiological tests to detect any beneficial effects of the chemical.
If the initial screening proves the new chemical to be worthy of further investigation, more animal tests are conducted. Animal tests are designed to determine The relative toxicity including LD50, including specific organ toxicity such as eyes, liver, and brain Animal tests are termed as preclinical investigations.
Prior to the institution of clinical testing in humans, the application is made by the sponsor to the FDA. This is referred to as IND or investigational new drug application. Information to furnished by the sponsor of the investigation includes The name of the drug, chemical name and structure of any new drug substance A complete list of components of the drug
The quantitative composition of the drug The name and address of supplier of any new drug substance if other than sponsor A statement of the methods, facilities and controls used for the manufacture, processing and packaging of the new drug A statement covering information derived from the preclinical studies.
Copies of the labels for the drugs and informational material The name and curriculum vitae of all investigators
An outline of the planned investigations of the new drug in humans. These investigations are divided into three phases. Phase 1: is the initial introduction of the drug into humans for the purpose of determining toxicity, metabolism, absorption, elimination, safe dose and pharmacological action
Phase 2: covers the initial trials for specific therapeutic effect and is conducted on a limited number of patients. Phase 3: of the clinical trial is intended to assess its safety and effectiveness in one or more particular indications. The regulations provide for a 30 day waiting period, after which if the FDA has not responded negatively, the clinical trials may commence.
In the clinical study The investigator will maintain required records of the study The investigator will inform patients that they are in an investigational drug study and obtain their consent for this involvement.
New drug application (NDA) The sponsor upon completion of clinical work to demonstrate the safety and effectiveness of the new drug for the use or uses for which it is intended may then submit a new drug application (NDA). this application must include in addition to the materials previously submitted to FDA in the IND
Detailed reports of the preclinical (animal) studies Reports of all clinical studies Information on the composition, manufacture of drug including controls and facilities used in its manufacture
Samples of the drug and its labeling Once a new drug application is approved, any significant change in the manufacturing, control, packaging or any change in the labeling must be covered by a supplemental new drug application. The requirement of an NDA for prescription and over the counter drugs is similar.
Once approved reports of human clinical experience are required to be submitted on the following basis During the first three years following the date of approval after every three monthly and annually there after
Abbreviated New Drug Application (ANDA)If the FDA agrees that a particularpharmaceutical company (other than innovatorcompany that is the original inventor of newdrug), companies wishes to manufacture andmarket the same product after or just beforethe expiry of innovator’s patent( that isexclusive right to manufacture and sale of newdrug), it can submit ANDA’s.
The following information is necessary to be furnished. Composition of the drug, stating the name and amount of each ingredient whether active or inactive in the dosage form
Identify the place where the drug will be manufactured, processed, packaged and labeled and the name of the supplier of the active ingredient (s). Includes certifications that the facilities used are in conformity with current good manufacturing practice
Outline the methods used in, facilities, controls used for the manufacture, processing and packing of the drug. Bioequivalence data For ANDA full clinical studies are not needed. FDA can grant approval for Abbreviated New Drug to the interested pharmaceutical companies after the completion of 5 years of NDA.