Active pharmaceutical ingredients update. Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers- September 2014

Transcription

1 Active pharmaceutical ingredients update. Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers- September 2014 Isabel Ortega-Antony Fake WHO Prequalification Team-Medicines 1

2 Reminder The API assessment covers three areas where API master file is common Linked to an FPP dossier submitted for PQ APIMF procedure API prequalification Standalone procedure Issue of a Confirmation of API Prequalification document (CPQ) APIMF Amendment procedure Changes to any APIMF 2

3 Progress Accepted APIMFs > 134 APIMFs currently active either in support of the API Prequalification and/or the APIMF procedure. API Prequalification Dates 1 Jan Jan Jan 2014 Presently Cumulative Number of APIs prequalified > Continues to increase. > In addition there are 43 further applications currently at some stage of progress. 3

4 API Prequalification highlights 2014 > 1 st Influenza API prequalified. > 1 st Zinc API prequalified. > Increased recognition within medicines regulatory authorities. List of Prequalified APIs on the website:

5 API Prequalification-Adding value > The API Prequalification status of an API has been officially recognised as a means to support a medicine application in Malaysia, the East African Community and in South Africa. > It is also extensively used within Southern Africa regulators (SADC). > This speeds the assessment of medicine applications with national agencies. > This recognition increases the value of API Prequalification to manufacturers. 5

6 Challenges > The number of accepted APIMFs has more than tripled since 2010, increasing workload. > The greatest challenge comes in the form of amendments: > These are changes to the details of accepted APIMFs. > They are very important to API supply and cover such changes as new manufacturing facilities, increases in manufacturing capacity, etc > Since the number of amendments received is proportional to the number of accepted APIMFs, amendment workload has increased significantly. 6

7 Assessment workload-what are we doing about this? 1. The elimination of paper based APIMF submissions 2. The introduction of a new amendment guidance 3. New and revised application forms 7

8 Introduction of electronic only submissions > In May 2014, paper based APIMF submissions were phased out in favour of electronic only submissions. > This is not true e-ctd, see website for details. > Basically the submitted APIMF must be in an electronic format that permits the assessor to navigate quickly through the document and copy key information from the APIMF into their report. > There is no doubt that better quality documentation aids assessors to shorten the review time. 8

9 Amendment guidance > In June 2014 a new amendment guidance was introduced. ion.htm > This is hoped to greatly reduce the workload on assessors and manufacturers. > Key feature: whereas previously all changes required assessment and an approval letter, this is no longer the case. Many changes are self-assessable by applicants. 9

10 Amendment categories > Annual notification (AAN) The change must be notified within 12 months of implementation. > Immediate notification (AIN) The change must be notified immediately upon implementation and can be considered acceptable if no objection is raised in 45 days from acknowledgment of receipt. > Minor amendment (Amin) The change can be implemented and considered accepted if no objection is raised 60 days following the acknowledgment of receipt. > Major amendment (Amaj) The change must not be implemented until approval has been given. 10

11 Amendments-To be effective For the amendment guidance to function effectively two principles must be adhered to: > The applicant must ensure they meet all conditions for the change category/severity and have all documents available, as described in the guidance. > The applicant must ensure they submit all required documents in the required format. Amendment applications not meeting the requirements consume assessment resources and prevent other applications from being advanced. Therefore such applications will not be accepted. 11

12 Future APIMF electronic only submissions New amendment guidance New and revised application forms We expect that these three recently introduced initiatives will shorten review times. 12

13 Other news 1-The dispatch of electronic letters for API-related correspondence: > Over the last 12 months we have stopped posting paper copies. Instead applicants have started receiving a signed PDF version. > The paper letter can still be sent if needed, but the PDF version is considered to be the official letter. 2- Article on API deficiencies recently published: 13

14 The PQ website is a good source of information, please read AND, ALSO Contact Please (or visit) us if you have any questions. Fakea@who.int (Dr Antony Fake-API Assessment Focal point) and cc stahlm@who.int (Dr Matthias Stahl -Group Leader-Medicines Assessment) One could save you a lot of time. 14

15 Acronyms > API: active pharmaceutical ingredient > APIMF: active pharmaceutical ingredient master file > CPQ: Confirmation of API Prequalification document > e-ctd: electronic common technical document > FPP: finished pharmaceutical product > SADC: Southern African Development Community 15