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Pharmaceutical Analysis II > ICH > Flashcards

ICH Flashcards

1
Q

is an initiative that brings together
regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.

A

International Council for Harmonisation of

Technical Requirements for Pharmaceuticals for Human Use (ICH)

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2
Q

mission of the ICH

A

to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.

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3
Q

Harmonisation leads to:

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.

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4
Q

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in
___ ___ at a meeting in_____

A

April 1990, Brussels.

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5
Q

the aim of these reforms (2015) was to transform ICH into a truly global initiative supported by a ____ and ___ ___ ___

A

robust and transparent governance structure

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6
Q

ICH Association established an Assembly

as the over-arching governing body

A

23 October 2015.

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7
Q

The ICH comprises the following bodies:

A
  • ICH Assembly
  • ICH Management Committee
  • MedDRA Management Committee
  • ICH Secretariat
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8
Q

brings together all Members and

Observers of the ICH Association as the overarching governing body of ICH.

A

ICH Assembly

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9
Q

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.

A

ICH Assembly

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10
Q

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).

A

ICH Management Committee (MC)

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11
Q

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.

A

MedDRA Management Committee (MC)

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12
Q

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

A

MedDRA

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13
Q

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.

A

ICH Secretariat

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14
Q

ICH harmonisation activities fall into 4

categories:

A
  • Formal ICH Procedure
  • Q&A Procedure
  • Revision Procedure
  • Maintenance Procedure
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15
Q

formal ICH procedure involves 5 steps:

A 
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
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16
Q

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.

A

Step 1: Consensus building
Experts sign-off sheet
Experts Technical Document

17
Q

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.

A

Step 2a: Confirmation of consensus on the

Technical Document

18
Q

is reached when the Regulatory Members of the Assembly further endorse the draft Guideline

A

Step 2b: Endorsement of draft Guideline by Regulatory Members

19
Q

Step 3 occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the Step 3 Expert Draft Guideline.

A

Step 3: Regulatory consultation and

discussion:

20
Q

3 stages of Step 3:

A

Stage I - Regional regulatory consultation
Stage II - Discussion of regional consultation comments
Stage III - Finalisation of Step 3 Experts
Draft Guideline

21
Q

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.

A

Stage I - Regional regulatory consultation:

22
Q

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___ ___ ___

A

Stage II Discussion of regional consultation
comments
Experts Draft Guideline

23
Q

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.

A

Stage III - Finalisation of Step 3 Experts

Draft Guideline

24
Q

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.

A

Step 4: Adoption of an ICH Harmonised

Guideline

25
Q

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.

A

Step 5: Implementation

26
Q

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:

A

Q : Quality Guidelines
S : Safety Guidelines
E : Efficacy Guidelines
M : Multidisciplinary Guidelines

27
Q 
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
A

S: Safety Guidelines

28
Q 
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
A

E: Efficacy Guidelines

29
Q 
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
A

M: Multidisciplinary Guidelines

30
Q

Pharmakon ? + Poeia ? = Pharmacopoeia

A

(Drug)

To make

31
Q

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.

A

PHARMACOPOEIA

Pharmaceutical Analysis II (3 decks)

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