1 2 3

4 5 6

8 December 2016 EMA/CVMP/EWP/707299/2015 Committee for Medicinal Products for Veterinary Use (CVMP)

Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea

7

Agreed by the CVMP’s Efficacy Working Party (EWP-V) Adopted by the Committee for Medicinal Products for Veterinary Use (CVMP) for release for consultation Start of public consultation End of consultation (deadline for comments)

September 2016 8 December 2016 16 December 2016 31 March 2017

8 9 10

The proposed guideline will replace the “Guideline on veterinary medicinal products for fluid therapy in case of diarrhoea” (NtA Volume 7, 7AE14a)

11 Comments should be provided using this template. The completed comments form should be sent to [email protected] 12 Keywords

veterinary medicinal product, fluid therapy, rehydration, electrolyte imbalances

13 14

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

15

1. Introduction

16

The guideline on veterinary medicinal products for fluid therapy in case of diarrhoea (7AE14a) was

17

adopted in March 1992 and has been in force since September 1992.

18

Following the review of current CVMP guidelines outlined in the ‘review and update of European

19

Medicines Agency guideline to implement best practice with regard to 3Rs (replacement, reduction and

20

refinement) in regulatory testing of medicinal products’ (EMA/CHMP/CVMP/JEG-3Rs/704685/2012), an

21

issue for review was noted in the guideline on veterinary medicinal products for fluid therapy in case of

22

diarrhoea (7AE14a; 1992) with regards to the 3Rs’ principles. Besides this issue, several other points

23

were noted.

24

2. Problem statement

25

The current guideline recommends that an untreated control group is included in clinical studies.

26

However, this may not always be possible for animal welfare reasons. Changes to the text could be

27

made to reflect this fact.

28

There have been very few applications for authorisation of new medicinal products for fluid therapy

29

indicated for diarrhoea, although dehydration can be caused by many other factors. The scope of the

30

guideline is narrow and some parts of the guideline are outdated. The guideline contains references to

31

the Directive and guidelines that have since been amended or replaced (e.g. Directive 81/852/EEC and

32

Good Clinical Practices, VICH GL 9).

33

3. Discussion (on the problem statement)

34

In the current guideline it is mentioned that for efficacy evaluation the test products could be

35

compared with a product approved in accordance with requirements of Directive 81/852/EEC. In

36

addition to this, there is a request for comparison to an untreated control group, unless justified. The

37

inclusion of a negative control is beneficial to ensure internal validity. However, this design may for

38

animal welfare reasons not be an option for severely affected animals. The text could be revised to

39

better reflect appropriate study design options taking study quality as well as animal welfare into

40

account. Furthermore, a broadening of the scope of this guideline is considered to include

41

recommendations on clinical efficacy and safety evaluation for different types of fluid therapy and for

42

different disease conditions and not only for animals suffering from diarrhoea. However, the purpose of

43

fluid therapy as stated in the guideline will remain: to correct dehydration and/or electrolyte

44

imbalances and/or metabolic imbalances and, if need be, energy losses. Such broadening of the scope

45

of the guideline may form incentives for future applications of new veterinary medicinal products.

46

4. Recommendation

47

The CVMP recommends revising the current guideline to provide more detailed and relevant

48

information regarding the selection of control groups, taking quality aspects of the study as well as

49

animal welfare into consideration. Furthermore, a broadening of the scope could be considered to

50

include recommendations on clinical efficacy and safety evaluation for different types of fluid therapy

51

and for different disease conditions.

52

5. Proposed timetable

53

8 December 2016

Concept paper adopted by CVMP for release for consultation

Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea EMA/CVMP/EWP/707299/2015

Page 2/3

54

31 March 2017

Deadline for comments from interested parties

55

Q2-Q3 2018

Expected date for adoption of the revised guideline by EWP-V

56

Q3-Q4 2018

Expected date for adoption of the revised guideline by CVMP for release for

57

consultation

58

6. Resource requirements for preparation

59

Preparation of the revision would involve one rapporteur assisted by co-rapporteur(s).

60

Preparation of the draft guideline will require discussion at EWP-V plenary meetings, and drafting

61

group meetings (virtual), as needed.

62

7. Impact assessment (anticipated)

63

The revised guideline is not intended to increase the requirements for marketing authorisation

64

applications. The review and update of existing guideline might be more appropriate for authorization

65

of medicinal products for fluid therapy.

66

8. Interested parties

67

Veterinary pharmaceutical industry and consultants.

68

Regulatory authorities.

69

Scientific veterinary associations, e.g. FVE (Federation of Veterinarians of Europe), European College of

70

Veterinary Internal Medicine Companion Animals (ECVIM CA), European Veterinary Emergency and

71

Critical Care Society (EVECCS), European College of Equine Internal Medicine (ECEIM).

72

9. References to literature, guidelines, etc.

73

Concept paper on review and update of EMA guidelines to implement best practice with regard to 3Rs

74

(replacement, reduction and refinement) in regulatory testing of medicinal products

75

(EMA/CHMP/CVMP/JEG-3Rs/704685/2012).

Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea EMA/CVMP/EWP/707299/2015

Page 3/3

Concept paper for the revision of the guideline on veterinary medicinal ...

Dec 8, 2016 - fluid therapy as stated in the guideline will remain: to correct dehydration and/or electrolyte. 43 imbalances and/or metabolic imbalances and, ...

81KB Sizes 0 Downloads 75 Views

Recommend Documents

Concept paper for the revision of the guideline on veterinary medicinal ...
Dec 16, 2016 - Medicines Agency guideline to implement best practice with regard to 3Rs ... is not intended to increase the requirements for marketing authorisation ... e.g. FVE (Federation of Veterinarians of Europe), European College of.

Concept paper on the revision of the guideline for 4 veterinary ...
Dec 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... oestrus, terminate unwanted gestation, prepare donors and recipients for the implantation of ... by appropriate data e.g. peer reviewed literature or own clinical.

Concept paper on the need for revision of the guideline on the clinical ...
Aug 1, 2016 - Comments should be provided using this template. .... update, simplification and restructuring according to the new template. .... ICH Topic E 11.

Concept paper on revision of the Guideline on clinical development of ...
Jun 23, 2017 - It covers the design of clinical development. 16 ... consideration of size of the pre-licensure safety database by type of vaccine and its novelty;.

Draft guideline on the higher-tier testing of veterinary medicinal ...
Jul 25, 2016 - Endpoints include adult mortality, and the number and age stage of. 155 ... species are active in the region hosting the study (typically spring).

Concept paper on the need for revision of the Note for Guidance on ...
Jul 21, 2016 - domains, e.g. cognition, are paramount across CNS disorders and warrant ... acceptance of the diagnostic and assessment tools available (7).

Guideline on user safety of topically administered veterinary medicinal ...
Jun 27, 2016 - into contact with the animals after administration of a topical product. .... be assessed in order to identify the potential adverse health effects. 124.

Guideline on clinical investigation of medicinal products for the ...
14 Dec 2017 - ACPA. Anti-citrullinated peptide/protein antibodies. ACR. American College of Rheumatology. CCP. Anti-cyclic citrullinated protein/peptide. CDAI. Clinical Disease Activity Index. CHMP. Committee for Human Medicinal Products. CRP. C-reac