Asia-Pacific Roundup: Japan revises postmarket safety controls ahead of launch of generic lenalidomide

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has set out the safety control measures it plans to implement in response to the launch of generic versions of Bristol Myers Squibb’s blood cancer drug Revlimid (lenalidomide).

The dispensing of lenalidomide Japan is covered by the RevMate control procedures because the drug molecule has a similar chemical structure to thalidomide and was shown to cause birth defects and abnormalities in animal studies. Japan’s procedures are intended to ensure that physicians, pharmacists and patients understand the measures before they are registered in the RevMate Center. Patients need to periodically confirm their adherence to RevMate.

Until now, there has been a single supplier of Revlimid; generic formulations were approved in February. The generics are expected to come to market once they are listed on the Japanese National Health Insurance drug price list.

PMDA wants Bristol Myers and its generic rivals to “share a safety management system and work closely together in the operation of the system.” Tasks such as the management and operation of the database and the training of prescribing physicians and responsible pharmacists that “are considered reasonable and efficient to be carried out in a concentrated manner” will be “implemented by the representative company.” Each company will need provide RevMate materials and handle special cases on their own.

PDMA also has created a joint steering committee to share knowledge and experience gained through the operation of the program, and changes to the consent form to inform patients that personal information will be provided to the companies that operate the RevMate Center.

The changes will take effect on 1 June.

PMDA Report

China’s CDE seeks feedback on translation of ICH bioanalytical method validation guideline

China’s Center for Drug Evaluation (CDE) has released translated versions of documents related to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) bioanalytical method validation guideline.

The guideline, ICH M10, and associated frequently asked question document came into effect in the EU in January. CDE released draft Chinese translations of the guideline and associated implementation suggestions for consultation in August.

Now, CDE has translated more documents into Chinese. The latest drafts, which are open for comment for one month, answer questions about the implementation of M10.

The English-language frequently asked questions document features three questions related to examples of nonclinical pharmacokinetic studies conducted as surrogates for clinical trials, the meaning of diluted concentrations, and the purpose of measuring the concentration of the quality control sample at time zero.

CDE also has translated a longer question-and-answer document that addresses nine questions on topics such as the use of a surrogate matrix to dilute samples, how to respond to failed time points in long-term stability studies and the investigation of trends of concern or incurred sample reanalysis failure.

CDE Notice

TGA adds five European countries to its mutual recognition GMP clearance pathway

Australia’s Therapeutic Goods Administration (TGA) has added the regulatory authorities in Croatia, Estonia, Romania, Slovenia and Lithuania to its existing mutual recognition agreement (MRA) with the European Union on good manufacturing practice (GMP) clearance applications.

Under the MRA pathway, companies can apply for GMP clearance with less supporting information than is required under the compliance verification pathway. TGA completes reviews under the MRA pathway in less time and at a lower cost because it relies in part on the approval of the overseas manufacturing site by a trusted regulatory authority to inform its assessment.

The expansion of the MRA means Australian sponsors can submit GMP clearance applications that are supported by evidence from the regulatory authorities in Croatia, Estonia, Romania, Slovenia and Lithuania.

TGA updated its eBusiness Portal on 20 March to reflect the changes. Applications that include evidence from the five regulatory agencies and were submitted but not assessed prior to 20 March will be processed as MRA submissions. TGA will contact applicants about any fees paid and if the required evidence for the MRA pathway has not been submitted.

TGA Notice

Pakistan gives manufacturers 30 days to update finished product specifications in online portal

The Drug Regulatory Authority of Pakistan (DRAP) has asked the holders of pharmaceutical and biological drug registrations to update their finished product specifications and validated testing procedures.

DRAP issued the request in relation to the deployment of the Pakistan Integrated Regulatory Information Management System (PIRIMS), an online application management system for processing information related to the licensing, registration and inspection of pharmaceutical and biological drugs. The use of PIRIMS for various regulatory functions triggered a request for updated information.

“All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile/details in the PIRIMS at http://pirims.dra.gov.pk,” DRAP wrote in its notice.

DRAP, which published the notice last week, will keep the portal open for 30 days. The agency added that “afterwards no request shall be entertained” and “after the lapse of the due time for above-said activity, necessary regulatory fee may apply.”

DRAP Notice

Malaysia’s NPRA sets out initial response to review of neurodevelopmental safety of epilepsy drug

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published its initial response to data on the risk of autism spectrum disorders and intellectual disability in children whose mothers took the antiepileptic drug topiramate during pregnancy.

Late last year, NPRA learned that the European Medicines Agency (EMA) was reviewing the safety of the drug in light of an observational study linking use during pregnancy to neurodevelopmental disorders in children. EMA is still evaluating the evidence. In parallel, NPRA has assessed the use of topiramate in Malaysia and made initial recommendations.

NPRA found 43 reports with 76 adverse events suspected to be related to topiramate-containing products in the Malaysian database. None of the reports describe cases of autism spectrum disorder, intellectual disability or neurodevelopmental disorder in children following the use of topiramate during pregnancy. NPRA has received three reports of speech disorders.

While the safety review is ongoing, NPRA is advising healthcare professionals to be aware of the findings of the recent study of neurodevelopmental risks and to perform a pregnancy test before beginning treatment with topiramate.

NPRA Notice

Asia-Pacific Roundup: Japan revises postmarket safety controls ahead of launch of generic lenalidomide

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