MEDICINES CONTROL COUNCIL

Transcription

1 MEDICINES CONTROL COUNCIL STANDARDISED PACKAGE INSERTS FOR HUMAN MEDICINES The purpose of this document is to define the criteria for developing standardised package inserts (SPI) and for the use of an SPI within the regulatory process. The intention of the development of an SPI is to minimise inconsistencies in the core data of package inserts for the same multisource medicine (MSM) and to facilitate the registration process. This guideline represents the Medicines Control Council s current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive approach. Council reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. The MCC is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. Version 1 publication and implementation January 2010 MS M HELA REGISTRAR OF MEDICINES 2.18 SPIs for human medicines Oct09 v1.doc January 2010 Page 1 of 5

2 TABLE OF CONTENTS Page 1 Purpose 3 2 Format 3 3 Development 3 4 Use of an SPI 4 5 Review of an SPI by the Committee 5 6 Updating of an SPI SPIs for human medicines Oct09 v1.doc January 2010 Page 2 of 5

3 DEVELOPMENT AND USE OF STANDARDISED PACKAGE INSERTS 1 PURPOSE The purpose of this document is to define the criteria for developing standardised package inserts (SPIs) and for the use of an SPI within the regulatory process. 2 FORMAT The format of the SPI is that of a package insert according to Regulation 9(1) of Act 101 of 1965, as amended. 3 DEVELOPMENT 3.1 The intention of the development of an SPI is to minimise inconsistencies in the core data of package inserts for the same multisource medicine (MSM) and to facilitate the registration process. 3.2 An MSM is a medicine of which the patent rights on the molecule have expired. 3.3 Development of SPIs for Biological and Biosimilar medicines, Fixed Dose Combination medicines and medicated medical devices are excluded. The final recommendation to develop an SPI for a particular medicine is at the discretion of the Central Clinical Committee (CCC). 3.4 An SPI is developed by the secretariat using the following appropriate references: - the most recently Council-approved innovator package insert - Goodman & Gilman: The Pharmacological Basis of Therapeutics (pharmacological action and pharmacokinetics) - latest edition - Martindale: The Complete Drug Reference (for safety information only) - latest edition - USP Drug Information (supplementary reference) - latest edition. 3.5 Further references which may be allowed: - recently (within the past 24 months) updated package inserts for an approved MSM or an Old Medicine. 3.6 The principal document for development of an SPI must be the most recently approved package insert for the South African registered innovator medicine of the active ingredient(s). No indication or dosage outside those in the approved package insert for the innovator medicine is allowed. The package inserts for an Old Medicine or a registered MSM may, in some instances, be suitable as the principal document if recently updated. 3.7 References must form an integral part of the documentation for a particular SPI for the purposes of back referral and for tracking any changes subsequent to the initial SPI. - References used must be clearly identified in the drafting of an SPI with clear and specific cross-referencing between the content in the draft SPI and the reference. - The list of relevant references used must always accompany any submission of the SPI for review to the Clinical Committee. 3.8 Each version of an SPI (in the development process) must be clearly numbered. Each SPI must include the date of revision and the date of Council approval. 3.9 The title of an SPI must include the dosage forms(s), the strength(s) and the route(s) of administration on which it is based Each SPI must include, at the beginning of the document, the following: This is a guidance document. The information is the core information required for inclusion in a package insert for a medicine. It is the responsibility of the applicant to ensure that any new and/or up to date information is added to the package insert for a medicine, especially safety information, as soon as it becomes available and to make any other necessary amendments SPIs for human medicines Oct09 v1.doc January 2010 Page 3 of 5

4 3 Development - continued Additional information to a package insert must be motivated for and supported by appropriate references, as is applicable for any package insert content. Such information is subject to evaluation. The applicant remains responsible for the correctness and completeness of all information in the package insert for a medicine based on an SPI. It is the responsibility of the applicant to evaluate the accuracy, currency, reliability and correctness of the information of an SPI when used to develop a package insert for a medicine. The MCC does not accept liability as a result of incorrect use of information from an SPI The following wording must be included directly under the heading Side Effects and Special Precautions of each SPI: See the guidance document on Information for the Package Inserts for Human Medicines on the MCC website. If information is taken from an innovator package insert, the side effect section of the package insert must contain a statement that side effects reported during pre-marketing clinical studies, post-marketing spontaneous reports and post-marketing clinical studies (whichever is applicable) with the innovator molecule are similar for [TRADE NAME] and applicable to [TRADE NAME] An SPI must include all standard wording which is from time to time determined by Council (e.g. as appears in the General Information Guideline, or on the website) Records of each version must be kept on file to allow for amendments that were previously made to be identified and traced (even at a later stage). All SPIs should be captured on a dedicated database established within the Clinical Directorate for easy access and review Approved SPIs and how to use an SPI will be placed on the MCC website. The date that the SPI was last updated must be provided at the top of the document A record must be kept by the secretariat of the registration of all medicines which have been based on an SPI. 4 USE OF AN SPI 4.1 An SPI may be used - to develop the package insert of an MSM application for registration, or - to update the package insert of a previously approved package insert, including an innovator package insert. 4.2 An SPI may be used as a template, where the package insert is an identical copy of the SPI except for the medicine proprietary name, or it may be used to develop a package insert which is not identical to the SPI, but which contains the SPI information as well as additional information included by the applicant. 4.3 An SPI is a guidance document. The information in an SPI is the core information required for inclusion in a package insert for a medicine. - It is the responsibility of the applicant to ensure that any new and/or up to date information is added to the package insert for a medicine, especially safety information, as soon as it becomes available and to make any other necessary amendments. - Additional information to a package insert must be motivated for and supported by appropriate references, as is applicable for any package insert content. Such information is subject to evaluation. 4.4 The applicant remains responsible for the correctness and completeness of all information in the package insert for a medicine which is based on an SPI. It is the responsibility of the applicant to evaluate the accuracy, currency, reliability and correctness of the information of an SPI when used to develop a package insert for a medicine. The MCC does not accept liability as a result of incorrect use of information from an SPI SPIs for human medicines Oct09 v1.doc January 2010 Page 4 of 5

5 4 Use of an SPI - continued 4.5 The latest version of the guidance document on Package Inserts for Human Medicines, as on the MCC website, should always be consulted. If information is taken from an innovator package insert, the side effect section of the package insert must contain a statement that side effects reported during premarketing clinical studies, post-marketing spontaneous reports and postmarketing clinical studies (whichever is applicable) with the innovator molecule are similar for the medicine (for which the package insert is being developed) and applicable to the medicine. 4.6 When used for the updating of a previously approved package insert, the content of the SPI may not replace previously approved information when being submitted without the deletion of such information clearly being identified (as required for any proposed package insert amendment), and justified. 4.7 Any amendments made to a previously approved package insert, based on an SPI, must be identified in line with the requirements for package insert amendments, viz. square brackets for deletion, underlining for new text, broken underlining for reworded text. The previously approved package insert must be included in the submission. 4.8 The use of an SPI as part of an MSM application does not mean that any administrative and/or committee process can be by-passed. The use of an SPI is intended to facilitate the process that inconsistencies in the core data of package inserts for the same multisource medicine (MSM) can be minimised or avoided. An application for the registration of an MSM which does not utilise an SPI or where an SPI is not available will proceed as for any other application for registration of a medicine. 4.9 The final approval of a package insert for an MSM based on a Council approved SPI remains at the discretion of Council, as is the case for the package inserts of all medicines The applicant should state in the covering letter whether the package insert is identical to the SPI or whether the SPI was used to develop the package insert. 5 REVIEW OF AN SPI BY THE COMMITTEE 5.1 All references used must be listed and submitted and clearly cross-referenced to the content of the document by underlining the text in the reference which has been used. A copy of the most recently approved South African registered innovator package insert and other relevant references must be made available to the reviewer. 5.2 On resubmission of an SPI for review, the references, including the most recently approved South African innovator package insert, must be included. This is to avoid any deviation from an initial submission without proper reference. 5.3 All amendments made by the Committee must be strictly recorded, including the basis for such an amendment. 6 UPDATING OF AN SPI 6.1 All SPIs must be updated regularly. Any amendment to an innovator package insert which may have an effect on the clinical use of the medicine (especially more restrictive), needs to be reflected in the SPI SPIs for human medicines Oct09 v1.doc January 2010 Page 5 of 5