The United States Food and Drug Administration 's Investigational New Drug ( IND ) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312 . Similar procedures are followed in the European Union, Japan, and Canada due to regulatory harmonization efforts by the International Council for Harmonisation .
24-448: The IND application may be divided into the following categories: An IND application must also include an Investigator's Brochure intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients. Once an IND application is submitted, the FDA has 30 days to object to
48-550: A harmonised guideline that meets the objectives outlined in the concept paper and business plan. Face-to-face meetings of the WG will normally only take place during the biannual ICH meetings. Interim reports are made at each meeting of the assembly and made publicly available on the ICH website. ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure, depending on
72-415: A more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety , efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on clinical drug trials that "[a]bove all, the ICH has succeeded in aligning clinical trial requirements." In
96-644: Is biopharmaceuticals . About half of the INDs fail in preclinical and clinical phases of drug development. The FDA runs a medical marijuana IND program (the Compassionate Investigational New Drug program ). It stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President George H. W. Bush administration's desire to "get tough on crime and drugs." As of 2011, four patients continue to receive cannabis from
120-412: Is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration. Harmonisation leads to
144-460: Is based on previous human experience and on the pharmacology of the investigational product". The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially. Owing to the importance of
168-464: Is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol , such as: An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of
192-560: Is responsible for day-to-day management of ICH, coordinating ICH activities as well as providing support to the assembly, the MC and working groups. The ICH secretariat also provides support for the MedDRA MC. The ICH secretariat is located in Geneva, Switzerland. The ICH WGs are established by the assembly when a new technical topic is accepted for harmonisation, and are charged with developing
216-439: Is the body that oversees operational aspects of ICH on behalf of all members, including administrative and financial matters and oversight of the working groups (WGs). The MedDRA Management Committee (MC) is responsible for direction of MedDRA, ICH's standardised medical terminology. The MedDRA MC has the role of managing, supporting, and facilitating the maintenance, development, and dissemination of MedDRA. The ICH secretariat
240-462: Is then submitted to the assembly to request adoption under Step 2 of the ICH process. Step 2a is reached when the assembly agrees, based on the report of the WG, that there is sufficient scientific consensus on the technical issues for the technical document to proceed to the next stage of regulatory consultation. The assembly then endorses the Step 2a technical document. Step 2b is reached when
264-1006: The United States (US). As part of its guidance on good clinical practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US). [1] ( broken link ) If many clinical trials have been completed, tables that summarize findings across the various studies can be very useful to demonstrate outcomes in, e.g., different patient populations or different indications. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH )
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#1732787258441288-587: The 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels . ICH had the initial objective of coordinating the regulatory activities of
312-475: The European, Japanese and American regulatory bodies in consultation with the pharmaceutical trade associations from these regions, to discuss and agree the scientific aspects arising from product registration. Since the new millennium, ICH's attention has been directed towards extending the benefits of harmonisation beyond the founding ICH regions. In 2015, ICH underwent several reforms and changed its name to
336-408: The IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP) , the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the authoring of the IB in the European Union (EU), Japan , and
360-573: The IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42 . An IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use," per 21 CFR 312.6 Approximately two-thirds of both INDs and new drug applications (NDAs) are small-molecule drugs . The rest
384-534: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use while becoming a legal entity in Switzerland as a non-profit association. The aim of these reforms was to transform ICH into a truly global initiative supported by a robust and transparent governance structure. The ICH association established an assembly as the over-arching governing body with
408-444: The activity to be undertaken. The development of a new harmonised guideline and its implementation (the formal ICH procedure) involves 5 steps: The WG works to prepare a consensus draft of the technical document, based on the objectives set out in the concept paper. When consensus on the draft is reached within the WG, the technical experts of the WG will sign the Step 1 Experts sign-off sheet. The Step 1 Experts' technical document
432-420: The aim of focusing global pharmaceutical regulatory harmonisation work in one venue that allows pharmaceutical regulatory authorities and concerned industry organisations to be more actively involved in ICH's harmonisation work. The new assembly met for the first time on 23 October 2015. The ICH comprises the following bodies: The ICH assembly brings together all members and observers of the ICH association as
456-456: The body of information about an investigational product ("IP" or "study drug") obtained during a drug trial . The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials. An IB
480-645: The final step of the process that is the regulatory implementation. This step is carried out according to the same national or regional procedures that apply to other regional regulatory guidelines and requirements in the ICH regions. Information on the regulatory action taken and implementation dates are reported back to the assembly and published by the ICH secretariat on the ICH website. The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories: ICH guidelines are not binding, and instead implemented by regulatory members through national and regional governance. MedDRA
504-530: The government under the program. Sanctioned by Executive Order 13139 , the US Department of Defense employed an anthrax vaccine classified as an investigational new drug (IND) in its Anthrax Vaccine Immunization Program (AVIP). Investigator%27s Brochure In drug development and medical device development the Investigator's Brochure ( IB ) is a comprehensive document summarizing
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#1732787258441528-402: The overarching governing body of ICH. It adopts decisions in particular on matters such as on the adoption of ICH guidelines, admission of new members and observers, and the ICH association's work plans and budget. Member representatives appointed to the assembly are supported by ICH coordinators who represent each member to the ICH secretariat on a daily basis. The ICH Management Committee (MC)
552-467: The possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that
576-447: The regulatory members of the assembly further endorse the draft guideline. Step 3 occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the Step 3 expert draft guideline. Step 4 is reached when the regulatory members of the assembly agree that there is sufficient scientific consensus on the draft guideline and adopt the ICH harmonised guideline. The ICH harmonised guideline moves immediately to
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