Committee for Proprietary Medicinal Products

December 2003 meeting

The Committee for Proprietary Medicinal Products (CPMP) held its 99th plenary meeting on 16-17 December 2003¹. This was the last meeting of the 2001-2003 mandate of the CPMP.

Centralised procedure

The committee adopted one positive opinion on an initial marketing authorisation: Photobarr^® (porfimer sodium), from Axcan International Pharma BV, for the treatment of high-grade dysplasia in patients with Barrett's oesophagus. Photobarr^® was designated an orphan medicinal product in March 2002 and is the fifteenth orphan medicinal product to receive a positive CPMP opinion.

The CPMP also adopted an opinion recommending the suspension of the marketing authorisation of Forcaltonin^® 100IU solution for injection (recombinant salmon calcitonin) from Unigene UK Limited, because the company could not identify an authorised manufacturer to ensure the quality of the product. The opinion will be reviewed after one year.

Centralised procedure: statistics

Details of the cumulative status of centralised marketing authorisation applications and variation applications submitted to the EMEA during 1995-2002 and in 2003 are presented in Table 1.

Table 1. Status of applications under the EU centralised procedure during 1995-2002 and in 2003

Reference: Annex 1 to CPMP meeting report (EMEA/CPMP/6016/03)
Marketing authorisation applications
	1995-2002			2003
	Part A	Part B	Total	Part A	Part B	Total	Overall total
Submissions made since 1 January 1995	127	239	366	6	32	38	404
Consultations for medical devices^a	0	1	1	0	0	0	1
Withdrawn	20	53	73	2	2	4	77
CPMP Opinions:
Positive^b	92	155	247	7	17	24	271^c
Negative^d	1	4	5	1	1	2	7^e
Marketing authorisations granted by the European Commission	88	146	234	3	16	19	253^f
Variations and scientific advice
							Overall
	Part A	Part B	Total	Part A	Part B	Total	total
Type I variations	585	1132	1717	186	366	552	2269
Type II variations
Positive	405	511	916	178	186	364	1280
Negative	1	6	7	0	0	0	7
Extensions (Annex II applications)	44	44	88	5	12	17	105
Scientific advice			302			65	367
Follow up to scientific advice			50			10	60
Protocol assistance			13			17	30
Follow up to protocol assistance			4			5	9
Notes
^a 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 derivatives of human blood or plasma and Directive 2001/104/EC.
^b 15 of the positive opinions correspond to 15 orphan medicinal products. ^c The 271 positive opinions correspond to 207 substances.
^d In case of appeal the opinion will not be counted twice.
^e The seven negative opinions correspond to six substances (two of these negative opinions correspond to two orphan medicinal products).
^f The 253 marketing authorisations correspond to 191 substances.

References

1. EMEA press release, EMEA/CPMP/6016/03, 23 December 2003, www.emea.eu.int