New Vaccine, drug Drug Research & International Regulations

·           Convid-19 –New drug/ new vaccine: Thousand miles away!!! What is the International Protocol in manufacturing, approval of regulatory agencies, and then marketing of new vaccines or drug: There are four phases of Research which is being followed for last half century? But will Convid -19 allow such time? . Time is of essence

·          There is a long Road of Vaccine Development

·          Most potential new drugs & vaccines must undergo extensive research and rigorous clinical trials as part of their development and must obtain government regulatory approvals before they become available to the public.

·          Typically, even before clinical trials in humans start, potential new drugs & vaccines face several years of preclinical testing involving A) test-tube , or “in-vitro” studies in Lab , B) followed by testing in living  Lab animals .

International Protocol in Drug Research

·          Step 1 for discovery of new vaccine / drugs for Convid-19   : Preclinical testing evaluates the safety of the drug,  vaccines including surgical devices , or materials used to make the proposed method.

·          Step 2 for vaccine / drugs for Convid-19 : Seeking permission of  US FDA approval & seeking permission for Clinical trial :  The manufacturing authority then has to submit to the regulatory agency an Lab Investigational Report on proposed New Drug.  After completing preclinical testing, a research organization seeking US FDA approval submits to the regulatory agency an Investigational New Drug Application or an Investigational Device Exemption to begin clinical trials.

·          Step 3  for new vaccine drugs for Convid-19 The method then , after permission must undergo three or four phases of clinical trials. This what is followed globally and designated as

International Protocol in Drug Research

·          The Four Phases of US FDA Clinical Trials

 

International Protocol in Drug Research

International Politics in Contraceptive Research

·          Where is the fund?

·          Why Company will take the risk of financial loss/ litigation?

·          Generally, companies prefer to introduce new drug that are modifications of currently available products because they have already proven safe and effective and therefore require fewer clinical trials and less expense and time than developing completely novel drug .

·          International Protocol in Drug Research

·          The long Road of drug or vaccine development  .Most potential drugs/ vaccines   undergo extensive research and rigorous clinical trials as part of their development and must obtain government regulatory approvals before they become available to the public.

·          Typically, even before clinical trials in humans start, potential new contraceptives face several years of preclinical testing involving test-tube , or “in-vitro” studies, followed by testing in living  animals .

International Protocol in Drug Research

·          Preclinical testing evaluates the safety of the drug, device, or materials used to make the proposed method. After completing preclinical testing, a research organization seeking US FDA/ Local State approval will have to submit to the state regulatory agency on  Investigational New Drug Application or an Investigational New Device allowing to proceed for initiation  clinical trials. The method then must undergo three or four phases of clinical trials.

·           ·          . Time is of essence