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The European Medicines Agency (EMA) has released a report showing both successes and room for improvement regarding conditional marketing authorizations (CMAs).
CMA is one of the tools available to regulators to support the development of and early access to drugs that address unmet medical needs of patients in the European Union.
Drugs are granted CMA if the public health benefit of their immediate availability is thought to outweigh the risk of an authorization on the basis of less comprehensive data than normally required.
A CMA is valid for 1 year. As part of the authorization, the drug’s developer is obliged to carry out further studies to obtain complete data.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses the data generated by these specific post-authorization obligations at least annually to ensure the balance of benefits and risks of the drug continues to remain positive.
At the end of its assessment, the CHMP issues a recommendation regarding the renewal of the CMA or its conversion into a standard marketing authorization.
Overview
The EMA’s report summarizes the experience with CMAs from the first use of this authorization type in 2006 until June 30, 2016.
During this time, a total of 30 drugs have received a CMA, including several
hematology drugs—Adcetris (brentuximab vedotin),
Arzerra (ofatumumab), Blincyto (blinatumomab), Bosulif (bosutinib), Darzalex (daratumumab), and Pixuvri (pixantrone).
Eleven CMAs have been converted into standard marketing authorizations (including Arzerra’s CMA), 2 have been withdrawn for commercial reasons, and 17 are still conditional authorizations.
None of the drugs that still have CMAs have been authorized for more than 5 years. And none of the CMAs issued since 2006 have had to be revoked or suspended.
Successes
According to the EMA’s analysis, marketing authorization holders comply with the specific obligations imposed by the agency.
More than 90% of completed specific obligations did not result in major changes of scope, and about 70% of specific obligations did not require an extension to the originally specified timelines.
The report shows that it took an average of 4 years to generate the additional data needed and to convert a CMA into a full marketing authorization.
This suggests patients with life-threatening or seriously debilitating conditions had access to promising drugs much earlier than they would have under standard authorization.
Areas for improvement
The EMA’s analysis also revealed room for improvement.
The report showed that, relatively frequently, CMA was first
considered only during the assessment of the drug application, which meant granting a CMA took longer than intended.
Therefore, the EMA recommends that drug developers engage in early dialogue with the EMA
and prospectively plan to apply for a CMA.
The agency said this should support
prompt assessment of such applications and could also facilitate prompt
completion of additional studies and timely availability of
comprehensive data.
The EMA said another area for improvement is engaging other stakeholders involved in bringing drugs to patients—in particular, Health Technology Assessment bodies—to facilitate the generation of all data needed for decision-making through one development program. 
The European Medicines Agency (EMA) has released a report showing both successes and room for improvement regarding conditional marketing authorizations (CMAs).
CMA is one of the tools available to regulators to support the development of and early access to drugs that address unmet medical needs of patients in the European Union.
Drugs are granted CMA if the public health benefit of their immediate availability is thought to outweigh the risk of an authorization on the basis of less comprehensive data than normally required.
A CMA is valid for 1 year. As part of the authorization, the drug’s developer is obliged to carry out further studies to obtain complete data.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses the data generated by these specific post-authorization obligations at least annually to ensure the balance of benefits and risks of the drug continues to remain positive.
At the end of its assessment, the CHMP issues a recommendation regarding the renewal of the CMA or its conversion into a standard marketing authorization.
Overview
The EMA’s report summarizes the experience with CMAs from the first use of this authorization type in 2006 until June 30, 2016.
During this time, a total of 30 drugs have received a CMA, including several
hematology drugs—Adcetris (brentuximab vedotin),
Arzerra (ofatumumab), Blincyto (blinatumomab), Bosulif (bosutinib), Darzalex (daratumumab), and Pixuvri (pixantrone).
Eleven CMAs have been converted into standard marketing authorizations (including Arzerra’s CMA), 2 have been withdrawn for commercial reasons, and 17 are still conditional authorizations.
None of the drugs that still have CMAs have been authorized for more than 5 years. And none of the CMAs issued since 2006 have had to be revoked or suspended.
Successes
According to the EMA’s analysis, marketing authorization holders comply with the specific obligations imposed by the agency.
More than 90% of completed specific obligations did not result in major changes of scope, and about 70% of specific obligations did not require an extension to the originally specified timelines.
The report shows that it took an average of 4 years to generate the additional data needed and to convert a CMA into a full marketing authorization.
This suggests patients with life-threatening or seriously debilitating conditions had access to promising drugs much earlier than they would have under standard authorization.
Areas for improvement
The EMA’s analysis also revealed room for improvement.
The report showed that, relatively frequently, CMA was first
considered only during the assessment of the drug application, which meant granting a CMA took longer than intended.
Therefore, the EMA recommends that drug developers engage in early dialogue with the EMA
and prospectively plan to apply for a CMA.
The agency said this should support
prompt assessment of such applications and could also facilitate prompt
completion of additional studies and timely availability of
comprehensive data.
The EMA said another area for improvement is engaging other stakeholders involved in bringing drugs to patients—in particular, Health Technology Assessment bodies—to facilitate the generation of all data needed for decision-making through one development program.
The European Medicines Agency (EMA) has released a report showing both successes and room for improvement regarding conditional marketing authorizations (CMAs).
CMA is one of the tools available to regulators to support the development of and early access to drugs that address unmet medical needs of patients in the European Union.
Drugs are granted CMA if the public health benefit of their immediate availability is thought to outweigh the risk of an authorization on the basis of less comprehensive data than normally required.
A CMA is valid for 1 year. As part of the authorization, the drug’s developer is obliged to carry out further studies to obtain complete data.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses the data generated by these specific post-authorization obligations at least annually to ensure the balance of benefits and risks of the drug continues to remain positive.
At the end of its assessment, the CHMP issues a recommendation regarding the renewal of the CMA or its conversion into a standard marketing authorization.
Overview
The EMA’s report summarizes the experience with CMAs from the first use of this authorization type in 2006 until June 30, 2016.
During this time, a total of 30 drugs have received a CMA, including several
hematology drugs—Adcetris (brentuximab vedotin),
Arzerra (ofatumumab), Blincyto (blinatumomab), Bosulif (bosutinib), Darzalex (daratumumab), and Pixuvri (pixantrone).
Eleven CMAs have been converted into standard marketing authorizations (including Arzerra’s CMA), 2 have been withdrawn for commercial reasons, and 17 are still conditional authorizations.
None of the drugs that still have CMAs have been authorized for more than 5 years. And none of the CMAs issued since 2006 have had to be revoked or suspended.
Successes
According to the EMA’s analysis, marketing authorization holders comply with the specific obligations imposed by the agency.
More than 90% of completed specific obligations did not result in major changes of scope, and about 70% of specific obligations did not require an extension to the originally specified timelines.
The report shows that it took an average of 4 years to generate the additional data needed and to convert a CMA into a full marketing authorization.
This suggests patients with life-threatening or seriously debilitating conditions had access to promising drugs much earlier than they would have under standard authorization.
Areas for improvement
The EMA’s analysis also revealed room for improvement.
The report showed that, relatively frequently, CMA was first
considered only during the assessment of the drug application, which meant granting a CMA took longer than intended.
Therefore, the EMA recommends that drug developers engage in early dialogue with the EMA
and prospectively plan to apply for a CMA.
The agency said this should support
prompt assessment of such applications and could also facilitate prompt
completion of additional studies and timely availability of
comprehensive data.
The EMA said another area for improvement is engaging other stakeholders involved in bringing drugs to patients—in particular, Health Technology Assessment bodies—to facilitate the generation of all data needed for decision-making through one development program.