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Nghiên cứu thử nghiệm lâm sàng và đánh giá tính an toàn thuốc

Qua nhiều hội nghị, hội thảo quốc tế và trong nước ở nhiều chuyên ngành khác nhau chúng , phần lớn các tác giả công trình nghiên cứu đã áp dụng các biểu mẫu đánh giá theo đề cương quy định của thử nghiệm lâm sàng (clinical trials) của quy định CITI, FDA và tiêu chuẩn châu Âu (European Agency for the Evaluation of Medicinal Products_EMEA), hoặc Nhật Bản. Do vậy, các nghiên cứu thử nghiệm thuốc hoặc các thuốc, công cụ, dụng cụ y khoa (drugs, medical devices) trở nên chặt chẽ và có giá trị khoa học, đồng thời giúp cho các nhà lâm sàng, tiếp cận và làm các thử nghiệm như thế đúng quy trình và không vi phạm đạo đức tròn nghiên cứu.

Nhân đây, chúng tôi xin giới thiệu đến quý bạn đồng nghiệp các biểu mẫu chính thống có thể áp dụng tại nhiều quốc gia khác nhau về các lĩnh vực thử nghiệm kahcs nhau, chuyên ngành khác nhau để công trình nghiên cứu khoa học đúng phương pháp và đầy đủ hồ sơ. Anh (chị) có thể tham khảo thêm trang website: https://www.tga.gov.au/clinical-efficacy-and-safety-guidelines/ Clinical efficacy and safety guidelines (update 24Jan. 2017).

Để tìm kiếm các hướng dẫn bằng các từ khóa trên trang, sử dụng chức năng browser's 'Find' (Control-F or Edit, Find in most browsers). Một số chuyên mục khác có thể bạn đang quan tâm cũng có trên trang website này: Clinical pharmacology and pharmacokinetics | Alimentary tract and metabolism | Blood and blood-forming organs | Blood products (including biotech alternatives) | Cardiovascular system | Dermatologicals | Genito-urinary system and sex hormones | Anti-infectives for systemic use | Antineoplastic and immunomodulating agents | Rheumatology / musculoskeletal system | Nervous system | Respiratory system | Biostatistics | General | Radiopharmaceuticals and Diagnostic Agents | Allergy/Immunology

1. Clinical pharmacology and pharmacokinetics

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

EMA/CHMP/37646/2009 (pdf,166kb) (link is external)

Guideline o­n the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Effective: 15 September 2014

EMA/CHMP/EWP/280/96 (pdf,499kb) (link is external)

Guideline o­n the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)

Replaces: CPMP/EWP/280/96 Corr. Note for Guidance o­n Modified Release Oral and Transdermal dosage forms: Section II (Pharmacokinetic and Clinical Evaluation) (corrected version adopted by TGA 1 June 2014)

Effective: 1 June 2015

TGA annotation: For multiple strengths of generic TDDS products, bioequivalence studies should be performed at least o­n the lowest and highest strengths versus the corresponding innovator products. If an applicant considers that this is unnecessary in a particular case, a justification for not submitting bioequivalence data should be submitted in accordance with the ARGPM guidance o­n Biopharmaceutic studies.

CPMP/EWP/560/95/Rev. 1 Corr.* (pdf,833kb) (link is external)*

Guideline o­n the Investigation of Drug Interactions

Replaces: CPMP/EWP/560/95 (Adopted by TGA 19 April 2001), and EMEA/CHMP/EWP/297931/2008 Concept Paper o­n this topic (provided for information 10 February 2009)

Effective: 1 August 2014

CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** (pdf,233kb) (link is external)

Guideline o­n the Investigation of Bioequivalence

Replaces: CPMP/QWP/EWP/1401/98 (Adopted by TGA 12 February 2002)

Effective: 16 June 2011


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TGA annotation: While this guidance suggests that the design and conduct of the study should follow EU regulations o­n Good Clinical Practice, sponsors should note that the EU Note for Guidance o­n Good Clinical Practice (CPMP/ICH/135/95) has been adopted in Australia with TGA annotations. The procedure for abridged applications claiming essential similarity to a reference product (i.e., generics), which allows applications to be made to numerous Member States of the EU, based o­n bioequivalence with a reference product from o­ne Member State, does not apply in Australia. An application for registration of a generic product in Australia should generally include a bioequivalence study versus a leading brand obtained in Australia.

EMA/CHMP/600958/2010/Corr.* (pdf,138kb) (link is external)

Appendix IV of the Guideline o­n the Investigation o­n Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1

TGA annotation:

1.The procedure for abridged applications claiming essential similarity to a reference product (i.e., for generic medicines), which allows applications to be made to numerous Member States of the EU, based o­n bioequivalence with a reference product from o­ne Member State, does not apply in Australia. Unless otherwise justified, an application for registration of a generic medicine in Australia should generally include o­ne or more bioequivalence studies, each versus the Australian reference product. Directions given in this guideline regarding "non-EU reference products" (Section 2), and "Member State where the reference product is purchased from" (Table 2.1) should be disregarded in favour of the advice given in TGA Guidance 15: Biopharmaceutic studies.

2.Similarly, details of the (presumably most recent) EU Authority Inspection of the clinical and bioanalytical study sites and site of the PK and statistical analysis (Table 2.2) are GCP/GLP issues, and need not be provided.

3.Table 3.1 should be amended according to the metrics that are suitable for the product and/or study type.


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2. Product-specific bioequivalence guidance

The European Medicines Agency's (EMA) has published a series of finalised product-specific bioequivalence guidelines which summarise in a standardised format the relevant study design principles for the demonstration of bioequivalence for specific products.

Unless specified otherwise, the TGA accepts these product specific requirements for bioequivalence demonstration described in finalised guidelines o­n this page:

The TGA effective date of the individual guidance is the effective date of the individual guidance.

For those products which comply with the current non-product-specific bioequivalence guidance (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr) but not the product-specific guidance and for which an application to TGA is submitted within 2 years of the date of publication of the guidance, sponsors must provide a robust justification for not complying with the product-specific bioequivalence guideline.

EMA/618604/2008 (pdf,479kb) (link is external)

Questions & Answers: Positions o­n specific questions addressed to the pharmacokinetics working party

For information: 1 June 2014

EMEA/CHMP/EWP/192217/2009 (pdf,154kb) (link is external)
Guideline o­n bioanalytical method validation
Effective: 1 June 2013

CHMP/EWP/89249/2004 (pdf,98kb) (link is external)
Guideline o­n the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins
Effective: 6 January 2009

EMEA/CHMP/EWP/147013/2004 Corr (pdf,114kb) (link is external)

Guideline o­n the role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population

Effective: 24 August 2009


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EMEA/CHMP/SWP/28367/07 (pdf,83kb) (link is external)

Guideline o­n Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products

Effective: 26 June 2009

CHMP/EWP/185990/06 (pdf,68kb) (link is external)
Guideline o­n Reporting the results of Population Pharmacokinetic Analysis
Effective: 27 January 2009

CPMP/EWP/2339/02 (pdf,92kb) (link is external)

Guideline o­n the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function

Effective: 4 January 2006

EMA/83874/2014 (pdf,221kb) (link is external)

Guideline o­n the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Replaces: CHMP/EWP/225/02 Note for guidance o­n the evaluation of the Pharmacokinetics of medicinal products in patients with impaired renal function (Adopted by TGA 24 November 2004)

Effective: 10 November 2016

CPMP/EWP/1875/03/Final (pdf,149kb) (link is external)

Points to Consider o­n the Clinical Requirements of Modified Release Products Submitted as a Line Extension of an Existing Marketing Authorisation

Effective: 7 June 2005

EMA/CHMP/594085/2015 (pdf,199kb) (link is external)

Guideline o­n the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products

Replaces: CPMP/EWP/2655/99 Points to Consider o­n Pharmacokinetics and Pharmacodynamics in the Development of Antibacterial Medicinal Products(Adopted by TGA 19 April 2001)

Effective: 1 February 2017

3CC3A (pdf,39kb) (link is external)

Pharmacokinetic Studies in Man

Effective: 12 February 2002

3. Alimentary tract and metabolism

How to access a pdf document

EMA/CHMP/336243/2013 (pdf,219kb) (link is external)

Guideline o­n the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing

In place of: EMA/CHMP/462198/2012 Concept paper o­n the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation (provided for information 1 August 2014)

Effective: 2 February 2016

CPMP/EWP/1080/00 Rev. 1 (pdf,225kb) (link is external)

Guideline o­n clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

Replaces: CPMP/EWP/1080/00 (Adopted by TGA 23 October 2002)

Effective: 1 April 2014


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EMA/CHMP/EWP/342691/2009 (pdf,464kb) (link is external)

Guideline o­n the evaluation of drugs for the treatment of Gastro-oesophageal reflux disease

Effective: 15 September 2014

CPMP/EWP/2284/99 Rev. 1 (pdf,61kb) (link is external)

Guideline o­n the Development of New Medicinal Products for the Treatment of Crohn's Disease

Replaces: CPMP/EWP/2284/99 (Adopted by TGA 10 January 2002)

Effective: 25 February 2009

CHMP/EWP/18463/2006 (pdf,115kb) (link is external)

Guideline o­n the Development of New Medicinal Products for the Treatment of Ulcerative Colitis

Effective: 8 April 2009

EMA/CHMP/311805/2014 (pdf,164kb) (link is external)

Guideline o­n clinical evaluation of medicinal products used in weight management

Replaces: CPMP/EWP/281/96 Rev. 1 Guideline o­n Clinical Evaluation of Medicinal Products Used in Weight Control (Adopted by TGA 26 March 2010)

Effective: 6 January 2017

TGA annotation: If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied.


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EMEA/CHMP/EWP/517497/2007 (pdf,51kb) (link is external)

Guideline o­n Clinical Evaluation of Medicinal Products Used in Weight Control (CPMP/EWP/281/96 Rev 1)

Addendum o­n Weight Control in Children

Effective: 25 February 2009

CPMP/EWP/4937/03 (pdf,112kb) (link is external)

Guideline o­n Non-Clinical and Clinical Development of Medical Products for the Prevention of Nausea and Vomiting Associated with Cancer Chemotherapy

Effective: 16 March 2009

CPMP/EWP/785/97 Rev. 1 (pdf,231kb) (link is external)

Guideline o­n the evaluation of medicinal products for the treatment of irritable bowel syndrome
Replaces: CPMP/EWP/785/97 Points to consider o­n the evaluation of medicinal products for the treatment of Irritable Bowel Syndrome (adopted by TGA September 2004).

Effective: 25 May 2015

CPMP/EWP/863/98 (pdf,42kb) (link is external)

Points To Consider o­n Wording of Helicobacter Pylori Eradication Therapy in Selected SPC Sections
Effective: 15 December 2000

4. Blood and blood-forming organs

How to access a pdf document

CPMP/EWP/197/99 (pdf,44kb) (link is external)

Points to Consider Concerning Endpoints in Clinical Studies with Haematopoeitic Growth Factors for Mobilisation of Autologous Stem Cells

Effective: 19 April 2001

5. Blood products (including biotech alternatives)

How to access a pdf document

CHMP/BPWP/585257/2009 (pdf,147kb) (link is external)

Guideline o­n the clinical investigation of hepatitis B immunoglobulins

Effective: 2 February 2016

CHMP/BPWP/410415/2011 Rev 1 (pdf,246kb) (link is external)

Guideline o­n the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)

Replaces: EMEA/CPMP/BPWG/283/00 Note for Guidance o­n the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use (Adopted by TGA 12 March 2003)
Effective: 2 February 2016


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CPMP/BPWG/575/99 Rev. 1 (pdf,115kb) (link is external)

Guideline o­n the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use

Replaces: CPMP/BPWG/575/99 (Adopted by TGA 19 April 2001)

Effective: 10 February 2009

CPMP/BPWG/220/02 (pdf,142kb) (link is external)

Guideline o­n the Clinical Investigation of Human Plasma Derived Von Willebrand Factor Products

Effective: 1 June 2006

CPMP/BPWG/1089/00 (pdf,61kb) (link is external)

Guideline o­n the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products

Effective: 13 January 2005

EMA/CHMP/BPWP/572810/2013 (pdf,125kb) (link is external)

Concept paper o­n the need for revision of the guideline o­n the clinical investigation of plasma derived fibrin sealant/haemostatic products (CPMP/BPWG/1089/00) and the related Core SmPC

For information: 1 August 2014

CPMP/BPWG/2220/99 (pdf,168kb) (link is external)

Note for Guidance o­n the Clinical Investigation of Plasma Derived Antithrombin Products

Effective: 16 October 2003

TGA annotation: If a sponsor believes that the patient numbers specified in this guideline are not achievable in Australia, advice should be sought from the TGA.

EMA/CHMP/BPWP/144533/2009 Rev 1. (pdf,332kb) (link is external)

Guideline o­n the clinical investigation of recombinant and human plasma-derived factor VIII products (Rev. 1)

Replaces: EMA/CHMP/BPWP/144533/2009 Guideline o­n the clinical investigation of recombinant and human plasma-derived factor VIII products (Adopted by TGA 1 June 2014)

Effective: 10 November 2016

EMA/CHMP/BPWP/144552/2009 Rev 1 (pdf,332kb) (link is external)

Clinical investigation of recombinant and Human plasma-derived factor IX products

Replaces: EMA/CHMP/BPWP/144552/2009

Guideline o­n clinical investigation of recombinant and human plasma-derived factor IX products (Adopted by TGA 1 June 2014)

Effective: 1 September 2015

EMA/CHMP/BPWP/94033/2007 rev. 2 (pdf,220kb) (link is external)

Guideline o­n the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

Replaces: CPMP/BPWG/388/95 Rev 1 (Adopted by TGA 19 April 2001)

Effective: 1 June 2014

6. Cardiovascular system

In this section: Hypertension | Lipid disorders | Pulmonary arterial hypertension | Arrythmias | Venous thromboembolism | Heart failure | Coronary artery disease (CAD) | Other


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7. Hypertension

How to access a pdf document

EMA/CHMP/29947/2013/Rev. 4 (pdf,212kb) (link is external)

Guideline o­n clinical investigation of medicinal products in the treatment of hypertension

Replaces: EMA/238/1995/Rev. 3 Guideline o­n clinical investigation of medicinal products in the treatment of hypertension (Adopted by TGA 17 August 2015)

Effective: 6 January 2017

EMA/CHMP/50549/2015 (pdf,114kb) (link is external)

Reflection paper o­n assessment of cardiovascular safety profile of medicinal products

Published for information January 2017

EMA/CHMP/206815/2013 (pdf,191kb) (link is external)

Paediatric addendum to the note for guidance o­n the clinical investigation o­n medicinal products in the treatment of hypertension

In place of: EMEA/CHMP/EWP/545456/2008 Concept Paper o­n the Need for the Development of a Paediatric Addendum to the Note for Guidance o­n the Clinical Investigation o­n Medicinal Products in the Treatment of Hypertension (Provided for information 1 May 2009)

Effective: September 2015

8. Lipid disorders

EMA/CHMP/748108/2013, Rev. 3 (pdf,204kb) (link is external)

Guideline o­n clinical investigation of medicinal products in the treatment of lipid disorders

Replaces: EMA/CHMP/748108/2013 Guideline o­n clinical investigation of medicinal products in the treatment of lipid disorder (Adopted by TGA 1 August 2014)

Effective: 6 January 2017

EMA/CHMP/494506/2012 (pdf,124kb) (link is external) (EMEA/CHMP/EWP/213057/2010)

Paediatric addendum to CHMP guideline o­n clinical investigation of medicinal products in the treatment of lipid disorders

In place of: EMEA/CHMP/EWP/350495/2009 Concept paper (provided for information 26 March 2010)

Effective: 1 August 2014


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9. Pulmonary arterial hypertension

EMEA/CHMP/EWP/356954/2008 (pdf,62kb) (link is external)

Guideline o­n the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension

Effective: 28 May 2010

EMA/CHMP/213972/2010 (pdf,105kb) (link is external)

Paediatric Addendum to the CHMP Guideline o­n the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension

In place of: EMEA/CHMP/EWP/644261/2008 concept paper o­n this topic (provided for information 1 May 2009)

Effective: 1 August 2014


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10. Arrythmias

EMA/CHMP/341363/2014 (pdf,264kb) (link is external)

Guideline o­n clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation

Effective: 26 December 2014

TGA annotation:

·Section 8.1:

·The collection of plasma/serum samples for the measurement of drug level and/or anticoagulant effect at the time of outcome events (e.g. bleeding, SEE, stroke) is recommended.

·The dossier must include specific discussion regarding non-specific and specific reversal agents and/or antidotes.

·The dossier must include a discussion regarding the utility of routine and/or ad hoc laboratory monitoring (drug levels or measures of anticoagulant effect) for the safe and efficacious use of the product. The availability of the laboratory tests mentioned should be included in the discussion.

·Section 6.2 (3):

·Where a study includes outcomes from 'VKA-naïve patients' meeting the definition provided in this guidance, a sensitivity analysis must be conducted with results from patients with no previous VKA exposure.

CHMP/ICH/2/04 (pdf,219kb) (link is external)

ICH Topic E 14

Note for Guidance o­n Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

Effective: 9 February 2006

TGA annotation:

QT prolongation would be of regulatory concern if either the estimated QT prolongation was >5ms OR the upper bound of the 95% confidence interval was >10ms


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EMA/CHMP/ICH/310133/2008 (pdf,176kb) (link is external)

ICH guideline E14 - questions and answers [on CHMP/ICH/2/04. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs]

Effective: 15 September 2014

CPMP/EWP/237/95 (pdf,73kb) (link is external)

Note for guidance o­n antiarrhythmics

Effective: August 1997

EMA/CHMP/EWP/213056/2010 (pdf,177kb) (link is external)

Addendum to the Guideline o­n antiarrhythmics o­n atrial fibrillation and atrial flutter [CPMP/EWP/237/95]

Effective: 15 September 2014

10. Venous thromboembolism

How to access a pdf document

EMA/CHMP/325170/2012 (former CPMP/EWP/707/98 Rev. 1 corr) (pdf,227kb) (link is external)

Guideline o­n clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery

Replaces: CPMP/EWP/707/98 Rev 1 Guideline o­n Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-Operative Venous Thromboembolic Risk (Adopted by TGA 8 December 2008)

Effective: 1 August 2014


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CPMP/EWP/6235/04 (pdf68,kb) (link is external)

Guideline o­n Clinical Investigation of Medicinal Products for the Prophylaxis of Venous Thromboembolic Risk in Non-Surgical Patients

Effective: 29 September 2006

EMA/CHMP/41230/2015 (pdf,225kb) (link is external)

Guideline o­n clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Replaces: CPMP/EWP/563/98 Note for Guidance o­n Clinical Investigation of Medicinal Products for the Treatment of Venous Thromboembolic Disease (Adopted by TGA 25 January 2001)

Effective: 10 November 2016

Ngày 09/10/2017
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