ICH Flashcards
is an initiative that brings together
regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH)
mission of the ICH
to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
Harmonisation leads to:
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.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in
___ ___ at a meeting in_____
April 1990, Brussels.
the aim of these reforms (2015) was to transform ICH into a truly global initiative supported by a ____ and ___ ___ ___
robust and transparent governance structure
ICH Association established an Assembly
as the over-arching governing body
23 October 2015.
The ICH comprises the following bodies:
- ICH Assembly
- ICH Management Committee
- MedDRA Management Committee
- ICH Secretariat
brings together all Members and
Observers of the ICH Association as the overarching governing body of ICH.
ICH Assembly
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 _____ are supported by ICH Coordinators who represent each Member to the ICH Secretariat on a daily basis.
ICH Assembly
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).
ICH Management Committee (MC)
has responsibility 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.
MedDRA Management Committee (MC)
is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans.
It is used for registration, documentation and safety monitoring of medical products both before and after
a product has been authorised for sale.
Products covered by the scope of ____ include pharmaceuticals, vaccines and drug-device combination products
MedDRA
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. It also provides support for the
MedDRA MC and is located in Geneva, Switzerland.
ICH Secretariat
ICH harmonisation activities fall into 4
categories:
- Formal ICH Procedure
- Q&A Procedure
- Revision Procedure
- Maintenance Procedure
formal ICH procedure involves 5 steps:
Step 1: Consensus building Step 2a: Confirmation of consensus on the Technical Document Step 3: Regulatory consultation and discussion Step 4: Adoption of an ICH Harmonised Guideline Step 5: Implementation
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___ ___ ___.
The Step 1 ___ ____ ___ is then submitted to the Assembly to request adoption under Step 2 of the ICH process.
Step 1: Consensus building
Experts sign-off sheet
Experts Technical Document
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 2a: Confirmation of consensus on the
Technical Document
is reached when the Regulatory Members of the Assembly further endorse the draft Guideline
Step 2b: Endorsement of draft Guideline by Regulatory Members
Step 3 occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the Step 3 Expert Draft Guideline.
Step 3: Regulatory consultation and
discussion:
3 stages of Step 3:
Stage I - Regional regulatory consultation
Stage II - Discussion of regional consultation comments
Stage III - Finalisation of Step 3 Experts
Draft Guideline
Guideline embodying the scientific
consensus leaves the ICH process and
becomes the subject of normal wide-ranging regulatory consultation in the ICH regions.
Regulatory authorities and industry
associations in other regions may also
comment on the draft consultation
documents by providing their comments to the ICH Secretariat.
Stage I - Regional regulatory consultation:
After obtaining all comments from the
consultation process, the EWG works to
address the comments received and reach consensus on what is called the Step 3___ ___ ___
Stage II Discussion of regional consultation
comments
Experts Draft Guideline
after due consideration of the consultation results by the WG, consensus is reached amongst the experts on a revised version of the Step 2b Draft Guideline, the Step 3 Expert Draft Guideline is signed by the experts of the ICH Regulatory Members. The Step 3 Expert Draft Guideline with regulatory EWG signatures is submitted to the Regulatory Members of the Assembly to request adoption at Step 4 of the ICH process.
Stage III - Finalisation of Step 3 Experts
Draft Guideline
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.
Step 4: Adoption of an ICH Harmonised
Guideline
The ICH Harmonised Guideline moves
immediately to the final step of the process that is the regulatory implementation.
This step is carried out according to the
same national/regional procedures that apply to other regional regulatory guidelines and requirements in the ICH regions.
Step 5: Implementation
ICH Guidelines are not mandatory for anybody per se but the strength of the ICH process lies in the commitment for
implementation by ICH Regulatory Members using appropriate national/regional tools.
ICH topic codes are assigned according to these categories:
Q : Quality Guidelines
S : Safety Guidelines
E : Efficacy Guidelines
M : Multidisciplinary Guidelines
Q1A-Q1F - Stability Q2 - Analytical Validation Q3A-Q3D - Impurities Q4-Q4B - Pharmacopoeias Q5A-Q5E - Quality of Biotechnological Products Q6A-Q6B - Specifications Q7 - Good Manufacturing Practice Q8 - Pharmaceutical Development Q9 - Quality Risk Management Q10 - Pharmaceutical Quality System Q11 - Development and Manufacture of Drug Substances
S: Safety Guidelines
E1-E2F - Clinical Safety E3 - Clinical Study Reports E4 - Dose-Response Studies E5 - Ethnic Factors E6 - Good Clinical Practice E7-E11 - Clinical Trials E12 - Clinical Evaluation by Therapeutic Category E14 - Clinical Evaluation E15-E16 - Pharmacogenomics
E: Efficacy Guidelines
S1Q-S1C - Carcinogenicity Studies S2 - Genotoxicity Studies S3A-S3B - Toxicokinetics and Pharmacokinetics S4 - Toxicity Testing S5 - Reproductive Toxicology S6 - Biotechnological Products S7A-S7B - Pharmacology Studies S8 - Immunotoxicology Studies S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals S10 - Photosafety Evaluation
M: Multidisciplinary Guidelines
Pharmakon ? + Poeia ? = Pharmacopoeia
(Drug)
To make
It is a legally binding, collection, prepared by a national or regional authority & contains list of medicinal substances, crude drug & formulas for making preparation from them.
PHARMACOPOEIA
