10 January 2017 EMA/18823/2017 Information Management Division

Monthly statistics report: December 2016 Medicinal products for human use (cumulative figures for the year to date)

This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. The purpose is only to provide ongoing factual information. Commentaries and analysis are provided in the Agency's annual reports.

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, 2017. Reproduction is authorised provided the source is acknowledged.

Table 1. Pre-authorisation: Marketing-authorisation applications* 2013

2014

2016†

2015

Started Finalised Started Finalised Started Finalised Started Finalised

Non-orphan medicinal products

48

46

37

42

36

41

40

28

Advanced-therapy medicinal products

0

2

1

0

0

1

0

0

Paediatric-use (PUMA) products

1

0

0

1

1

0

1

1

Well-established use, abridged, hybrid and informed consent products

6

4

12

15

8

7

7

5

Generic products

5

16

25

6

28

25

24

22

Similar biological products

1

4

3

3

12

2

14

7

61

72

78

67

85

76

86

63

16

14

20

17

24

20

27

16

2

0

1

1

1

1

1

2

79

86

99

85

110

97

114

81

New products

Sub-total product applications Orphan medicinal products◊ New products Advanced-therapy medicinal products Total product applications * † ◊

Finalised applications exclude applications withdrawn prior to opinion. Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year. These figures reflect the orphan status of the medicinal products at the time of the CHMP opinion. EMA’s Committee for Orphan

Medicinal Products (COMP) then assesses whether the orphan designation should be maintained.



Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: December 2016 EMA/18823/2017

Page 2/5

Table 2. Pre-authorisation: Outcome of the evaluation of marketing authorisation applications* 2013

2014

2015

2016

79

81

93

79

4

4

3

7

3

1

3

1

Negative opinions

7

4

4

2

Opinions after accelerated assessment**

5

7

5

7

Applications withdrawn prior to opinion

8

6

5

16

10

5

1

2

3

1

0

2

Positive opinions Opinions recommending conditional ** marketing authorisation Opinions under exceptional ** circumstances

Re-examinations requested Re-examination - Positive opinions



*

Applicants can request a re-examination. The first four rows present the outcome of the evaluation before a re-examination (or a re-consideration). The final row shows the number of changes from a negative to a positive opinion following a re-examination or a re-consideration.

**

Included in the figures for positive opinions.





Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: December 2016 EMA/18823/2017

Page 3/5

Table 3. Scientific services 2013

2014

2015

2016



Started Finalised Started Finalised Started Finalised Started Finalised

Compassionate-use opinions

2

2

1

1

0

0

0

0

Art. 58 (WHO) scientific opinions

1

1

1

1

1

1

0

1

3

1

0

1

1

1

0

0

19

13

16

16

17

19

19

22

Opinions on ancillary medicinal substances in medical devices* Plasma master file

(includes initial certification, variations and annual re-certification) * †

Consultation in accordance with Council Directive 93/42/EEC concerning medical devices as amended by Directive 2000/70/EC as regards medical devices incorporating stable derivates of human blood or plasma and Directive 2001/14/EC. Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: December 2016 EMA/18823/2017

Page 4/5

Table 4. Post-authorisation: Variations, renewals and annual reassessments 2013

2014

2016†

2015

Started

Started

Started

Finalised

Started

Finalised

Type IA variations

2,922

2,886

2,969

2,854

2,829

2,849

3,019 2,934

Type IB variations

1,958

1,597

1,886

1,986

1,954

1,838

2,000 1,988

Type II variations

961

946

1,151

1,103

1,168

1,097

1,185 1,131

Extensions of marketing authorisation

16

18

16

15

14

15

25

16

Annual reassessments

18

16

18

18

16

20

25

19

Renewals*

98

77

100

121

71

75

107

89

*



Started

Finalised

Includes renewals of conditional marketing authorisations. Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: December 2016 EMA/18823/2017

Page 5/5

monthly figures - December 2016 - European Medicines Agency

Jan 10, 2017 - Monthly statistics report: December 2016. EMA/18823/2017. Page 2/5. Table 1. Pre-authorisation: Marketing-authorisation applications*. 2013.

191KB Sizes 0 Downloads 62 Views

Recommend Documents

monthly figures - December 2016 - European Medicines Agency
Jan 10, 2017 - Applicants can request a re-examination. The first four rows present the outcome of the evaluation before a re-examination (or a.

monthly figures - February 2017 - European Medicines Agency
Mar 16, 2017 - Applicants can request a re-examination. The first four rows present the outcome of the evaluation before a re-examination (or a.

monthly figures - June 2016 - European Medicines Agency - Europa EU
Jul 12, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.

monthly figures - March 2017 - European Medicines Agency - Europa ...
Apr 13, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.

monthly figures - May 2017 - European Medicines Agency - Europa EU
Jun 21, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.

Orphan medicines figures 2000-2016 - European Medicines Agency
Orphan Medicines Figures. 2000- 2016. Orphan Medicines - Product Development Scientific Support. Page 2. 1. Orphan Applications Figures 2000-2016. 2000.

PDCO Monthly report 22-24 June 2016 - European Medicines Agency
Jun 30, 2016 - The PDCO adopted a positive opinion on (full) compliance check for: ... and the Paediatric Regulation is available in the Regulatory section.

July 2016 - European Medicines Agency - Europa EU
Jul 11, 2016 - EMA/COMP/451206/2016 ... Cannabidiol for treatment of graft-versus-host disease, Richardson Associates Regulatory ..... Best Regulatory.

October 2016 - European Medicines Agency - Europa EU
Nov 15, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.

July 2016 - European Medicines Agency - Europa EU
Information is selected based on recommendations from consulted patients, consumers ... need one of the following: a modern web browser; a web-based news reader or a ..... person developing the medicine must submit an application to the.

Organisational matters June 2016 - European Medicines Agency
Jun 24, 2016 - Send a question via our website www.ema.europa.eu/contact ... The main organisational topics addressed during the June meeting related to:.

Veterinary pharmacovigilance 2016 - European Medicines Agency
Feb 16, 2017 - monitoring of several centrally authorised products ..... regulatory tools within the EU that are ... Following to this, a Rapid alert was circulated.

July 2016 - European Medicines Agency - Europa EU
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).